metformin and Nausea

metformin has been researched along with Nausea in 41 studies

Metformin: A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)
metformin : A member of the class of guanidines that is biguanide the carrying two methyl substituents at position 1.

Nausea: An unpleasant sensation in the stomach usually accompanied by the urge to vomit. Common causes are early pregnancy, sea and motion sickness, emotional stress, intense pain, food poisoning, and various enteroviruses.

Research

Studies (41)

Authors

Clinical Trials (12)

Trial Overview

Trial Outcomes

Change in Body Weight (kg) (Week 52)

Change from baseline (week 0) in body weight to week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 52

Change in HbA1c (Week 52)

Change from baseline (week 0) in HbA1c to week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 52

Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product

Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. (NCT03021187)
Timeframe: Weeks 0-57

Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes

Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. (NCT03021187)
Timeframe: Weeks 0-57

Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes

Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. (NCT03021187)
Timeframe: Weeks 0-57

Change in Amylase - Ratio to Baseline

Change from baseline (week 0) in amylase (units/litre (U/L)) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. (NCT03021187)
Timeframe: Week 0, week 26, week 52

Change in Body Mass Index

Change from baseline (week 0) in body mass index (BMI) was evaluated at weeks 26 and 52. BMI was calculated based on body weight and height based on the formula: BMI kg/m^2 = body weight (kg)/(Height (m) x Height (m)). Data based on in-trial observation period is presented. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52

Change in Body Weight (Percentage)

Relative change from baseline (week 0) in body weight (%) was evaluated at weeks 26 and 52.The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52

Change in Body Weight (Week 26)

Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. The endpoint was also evaluated based on data from the on-treatment without rescue medication observation period. It started at the date of first dose of trial product and excluded the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26

Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed)

"Change from baseline (week 0) in Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) was evaluated at week 26 and week 52. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of hyperglycaemia and hypoglycaemia, respectively. Thus, lower scores indicate a perception of blood glucose levels being none of the time unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score has a minimum of 0 and a maximum of 36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction." (NCT03021187)
Timeframe: Week 0, week 26, week 52

Change in ECG Evaluation

Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and 52. Change from baseline results are presented as shift in findings (normal; abnormal and not clinically significant (NCS); abnormal and clinically significant (CS)) from week 0 to week 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT03021187)
Timeframe: Week 0, week 26, week 52

Change in Fasting Plasma Glucose (FPG)

Change from baseline (week 0) in FPG to week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52

Change in HbA1c (Week 26)

Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. The endpoint was also analysed based on data from the on-treatment without rescue medication observation period. On-treatment without rescue medication observation period started at the date of the first dose of trial product and includes the period after initiation of rescue medication, if any, and excludes the period after premature trial discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26

Change in HDL Cholesterol - Ratio to Baseline

Change from baseline (week 0) in HDL cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52

Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains

The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. The items of the IWQOL-Lite-CT pertain to physical functioning (physical, physical function and pain/discomfort) and psychosocial domains and all items employ a 5-point graded response scale (never, rarely, sometimes, usually, always; or not at all true, a little true, moderately true, mostly true, completely true). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. Results are based on the data from the in-trial observation period, which started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52

Change in LDL Cholesterol - Ratio to Baseline

Change from baseline in LDL cholesterol (mmol/L) is presented as ratio to baseline at week 26 and week 52. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52

Change in Lipase - Ratio to Baseline

Change from baseline (week 0) in lipase (units/litre (U/L)) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication (NCT03021187)
Timeframe: Week 0, week 26, week 52

Change in Pulse Rate

Change from baseline (week 0) in pulse rate was evaluated at weeks 26 and 52 Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. (NCT03021187)
Timeframe: Week 0, week 26, week 52

Change in SBP and DBP

Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at weeks 26 and 52 Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. (NCT03021187)
Timeframe: Week 0, week 26, week 52

Change in Self-measured Plasma Glucose (SMPG) Mean 7-point Profile

Change from baseline (week 0) in self-measured plasma glucose (SMPG) mean 7-point profile to week 26 and week 52. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52

Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)

SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26 and 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period. (NCT03021187)
Timeframe: Week 0, week 26, week 52

Change in SMPG Mean Postprandial Increment Over All Meals

Change from baseline (week 0) in SMPG mean postprandial increment over all meals to week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52

Change in Total Cholesterol - Ratio to Baseline

Change from baseline in total cholesterol (mmol/L) is presented as ratio to baseline at week 26 and week 52. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52

Change in Total Daily Insulin Dose

Change from baseline in total daily insulin dose to week 26 and week 52 is presented. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52

Change in Triglycerides - Ratio to Baseline

Change from baseline (week 0) in triglycerides (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52

Change in Waist Circumference

Change from baseline (week 0) in waist circumference was evaluated at weeks 26 and 52.The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52

Semaglutide Plasma Concentrations for Population PK Analyses

This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Semaglutide plasma concentrations were measured at week 4, 14, 26, 38 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. (NCT03021187)
Timeframe: Weeks 0-52

Time to Additional Anti-diabetic Medication

Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Additional anti-diabetic medication was defined as use of new anti-diabetic medication for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 52), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT03021187)
Timeframe: Weeks 0-52

Time to Rescue Medication

Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Rescue medication was defined as use of new anti-diabetic medication as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 1) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation. (NCT03021187)
Timeframe: Weeks 0-52

Change in Eye Examination Category

Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT03021187)
Timeframe: Week -2, week 52

Change in Physical Examination

Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2) and weeks 52 presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland. (NCT03021187)
Timeframe: Week -2, week 52

Participants Who Achieve Body Weight Loss ≥10% (Yes/no)

Participants who achieved weight loss more than or equal to 10% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. Results are based on the data from the in-trial observation period, which started at the date of randomisation and included the period after initiatiion of of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 26, week 52

Participants Who Achieve Body Weight Loss ≥5% (Yes/no)

Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 26, week 52

Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)

Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at weeks 26 and 52 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT03021187)
Timeframe: Week 26, week 52

Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)

Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT03021187)
Timeframe: Week 26, week 52

Participants Who Achieve: HbA1c < 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no)

Number of particpants achieving HbA1c < 7.0 % (53 mmol/mol) according to American Diabetes Association (ADA) target, at week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 26, week 52

Participants Who Achieve: HbA1c ≤ 6.5% (48 mmol/Mol) (AACE Target) (Yes/no)

Number of participants achieving HbA1c ≤ 6.5% (48 mmol/mol) according to American Association of Clinical Endocrinologists (AACE) target, at week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 26, week 52

Change From Baseline in Body Weight

Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares). (NCT03987919)
Timeframe: Baseline, Week 40

Change From Baseline in Fasting Serum Glucose (FSG)

Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares). (NCT03987919)
Timeframe: Baseline, Week 40

Change From Baseline in HbA1c (5 mg)

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares). (NCT03987919)
Timeframe: Baseline, Week 40

Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares). (NCT03987919)
Timeframe: Baseline, Week 40

Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values

The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares). (NCT03987919)
Timeframe: Baseline, Week 40

Percentage of Participants Achieving an HbA1c Target Value of <5.7%

Percentage of Participants Achieving an HbA1c Target Value of <5.7%. (NCT03987919)
Timeframe: Week 40

Percentage of Participants Achieving an HbA1c Target Value of <7%

Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. (NCT03987919)
Timeframe: Week 40

Percentage of Participants Who Achieved Weight Loss ≥5%

Percentage of Participants who Achieved Weight Loss ≥5%. (NCT03987919)
Timeframe: Week 40

Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] or Severe Hypoglycemia

The hypoglycemia events were defined by participant reported events with blood glucose <54mg/dL) (<3.0 mmol/L] or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of postbaseline hypoglycemia was estimated by negative binomial model: number of episodes = Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment. (NCT03987919)
Timeframe: Baseline through Safety Follow-Up (Up to Week 44)

Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Total Score

DTSQc, an 8-item questionnaire, assesses relative change in treatment satisfaction perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia from baseline to week 40 or early termination. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 to 18 where the higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. The hyperglycemia and hypoglycemia scores range from -3 to 3 where negative scores indicate fewer problems with blood glucose levels and positive scores indicate more problems than before. LS Mean was determined by ANCOVA with Baseline DTSQs + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment (Type III sum of squares). (NCT03987919)
Timeframe: Baseline, Week 40

Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required. (NCT01169779)
Timeframe: Baseline, Week 24

Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24

The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. (NCT01169779)
Timeframe: Baseline, Week 24

Change From Baseline in Body Weight at Week 24

Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required. (NCT01169779)
Timeframe: Baseline, Week 24

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required. (NCT01169779)
Timeframe: Baseline, Week 24

Change From Baseline in Glucose Excursion at Week 24

Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. (NCT01169779)
Timeframe: Baseline, Week 24

Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period

Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >250 milligram/deciliter (mg/dL) (13.9 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >220 mg/dL (12.2 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required. (NCT01169779)
Timeframe: Baseline up to Week 24

Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24

The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required. (NCT01169779)
Timeframe: Baseline, Week 24

Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24

The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required. (NCT01169779)
Timeframe: Week 24

Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24

The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required. (NCT01169779)
Timeframe: Week 24

Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia

Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available. (NCT01169779)
Timeframe: First dose of study drug up to 3 days after the last dose administration

Change From Baseline in 7-point Self-measured Plasma Glucose Profile

Mean change from baseline in mean of 7-point self-measured plasma glucose at week 26. The 7-point self-measured plasma glucose levels were measured before and after (120 minutes after the start of the meal) the three main meals (breakfast, lunch and dinner), and at bed time. (NCT02008682)
Timeframe: Week 0, week 26

Change From Baseline in Fasting Plasma Glucose

Mean change from baseline in fasting plasma glucose (FPG) at Week 26. (NCT02008682)
Timeframe: Week 0, week 26

Change From Baseline in Glycosylated Haemoglobin (HbA1c)

Mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26. (NCT02008682)
Timeframe: Week 0, week 26

Number of Confirmed Hypoglycaemic Episodes

confirmed hypoglycaemic episode defined as severe (unable to treat her/himself) or biochemically confirmed by a plasma glucose < 3.1 mmol/L (NCT02008682)
Timeframe: Weeks 0-26

Subjects Who Achieve (Yes/no) HbA1c Below 7.0 % (American Diabetes Association Target)

Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26 (NCT02008682)
Timeframe: After 26 weeks of treatment

Subjects Who Achieve (Yes/no) HbA1c Below or Equal to 6.5 % (American Association of Clinical Endocrinologists Target)

Calculated as the percentage of subjects achieving treatment target of HbA1c <= 6.5% at Week 26 (NCT02008682)
Timeframe: After 26 weeks of treatment

Change From Baseline in Body Weight at Week 30

Change in body weight following 30 weeks of therapy (i.e., body weight at Week 30 minus body weight at baseline) (NCT00993187)
Timeframe: Baseline and Week 30

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30

Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 30 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 30 minus FPG at baseline). (NCT00993187)
Timeframe: Baseline and Week 30

Change From Baseline in Hemoglobin A1C (HbA1C) at Week 30

HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Change in A1C following 30 weeks of therapy (i.e., A1C at Week 30 minus A1C at baseline). (NCT00993187)
Timeframe: Baseline and Week 30

Number of Participants Who Discontinued Study Drug Due to an Adverse Event

An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product. (NCT00993187)
Timeframe: Up to 30 weeks

Number of Participants Who Experienced at Least One Adverse Event (AE)

An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product. (NCT00993187)
Timeframe: Up to 32 weeks

Percentage of Participants With HbA1C < 7.0% at Week 30

HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). (NCT00993187)
Timeframe: Week 30

Percentage of Participants With One or More Episodes of Hypoglycemia

Symptomatic episodes assessed as likely to be due to hypoglycemia were reported by investigators as adverse experiences of hypoglycemia. Adverse experiences of hypoglycemia were based on all reports of hypoglycemia; a concurrent glucose measurement was not required. (NCT00993187)
Timeframe: Up to Week 30

Change in Body Weight

Change from baseline in body weight was analysed after 26 weeks of treatment. Analysis population set: FAS: all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using MMRM. (NCT01907854)
Timeframe: From baseline to week 26

Change in Fasting Plasma Glucose

Change from baseline in fasting plasma glucose was analysed after 26 weeks of treatment. Missing values were imputed using MMRM. (NCT01907854)
Timeframe: From baseline to week 26

Change in HbA1c (Glycosylated Haemoglobin)

Change from baseline in HbA1c was analysed after 26 weeks of treatment. Analysis population set: full analysis set (FAS); all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using mixed model for repeated measurements (MMRM). (NCT01907854)
Timeframe: From baseline to week 26

Number of Treatment Emergent Adverse Events (TEAEs)

A treatment emergent adverse event (TEAE) was defined as an event that had an onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. The number of TEAEs was recorded during 26 weeks of treatment plus one week follow-up period. (NCT01907854)
Timeframe: During 26 weeks of treatment plus one week follow-up period.

Change in Fasting Blood Lipids

Ratio to baseline in fasting blood lipids (total cholesterol, low density lipoprotein [LDL], very low density lipoprotein [VLDL], high density lipoprotein [HDL], triglycerides, and free fatty acids) were analysed after 26 weeks treatment. Missing values were imputed using MMRM. Here we are presenting ratio to baseline data. (NCT01907854)
Timeframe: From baseline to week 26

Change in Systolic Blood Pressure and Diastolic Blood Pressure

Change from baseline in systolic and diastolic blood pressure were analysed after 26 weeks of treatment. Missing values were imputed using MMRM. (NCT01907854)
Timeframe: From baseline to week 26

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association Target) (y/n)

Number of subjects who achieve HbA1c <7.0% were analysed after 26 weeks of treatment. Missing values were imputed using MMRM. (NCT01907854)
Timeframe: After 26 weeks of treatment

Change in Beta-cell Function

Change in homeostatic model assessment-beta cell (HOMA-B) from baseline to endpoint (Week 26) (outcome measure is presented as the ratio of endpoint HOMA-B divided by baseline HOMA-B). HOMA-B is a measure of pancreatic beta-cell function. (NCT00603239)
Timeframe: baseline and 26 weeks

Change in Body Weight

Change in body weight from baseline to endpoint (26 weeks) (NCT00603239)
Timeframe: baseline and 26 weeks

Change in Fasting Serum Glucose (FSG)

Change in FSG from baseline to endpoint (26 weeks) (NCT00603239)
Timeframe: baseline and 26 weeks

Change in Glycosylated Hemoglobin (HbA1c)

Change in HbA1c from baseline to endpoint after 26 weeks of treatment (i.e., HbA1c at endpoint minus HbA1c at baseline) (NCT00603239)
Timeframe: baseline and 26 weeks

Change in Insulin Sensitivity.

Change in homeostatic model assessment-insulin sensitivity (HOMA-S) from baseline to endpoint (26 weeks) (outcome measure is presented as the ratio of endpoint HOMA-S divided by baseline HOMA-S). (NCT00603239)
Timeframe: baseline and 26 weeks

Change in Waist Circumference

Change in waist circumference from baseline to endpoint (26 weeks) (NCT00603239)
Timeframe: baseline and 26 weeks

Number of Subjects Who Experienced an Episode of Minor Hypoglycemia

Overall number of subjects who experienced an episode of minor hypoglycemia. (NCT00603239)
Timeframe: 26 weeks

Percentage of Patients Achieving HbA1c <= 6.5%

Percentage of ITT patients who had achieved HbA1c <= 6.5% at endpoint (Week 26 or early discontinuation) (NCT00603239)
Timeframe: 26 weeks

Percentage of Patients Achieving HbA1c <= 7%

Percentage of intent-to-treat (ITT) patients who had HbA1c > 7% at baseline that decreased to <= 7% at endpoint (Week 26 or early discontinuation) (NCT00603239)
Timeframe: 26 weeks

Change in Euroqol - 5 Domain Quality of Life (EQ-5D) Score

EQ-5D Score - change from baseline to endpoint (26 weeks). EQ-5D is a 5-item questionnaire used to characterize current health states. The tool and accompanying visual analog scale (VAS) assess 5 domains of quality of life, including mobility, self-care, usual activity, pain, and anxiety/depression. Weights are used to score the responses to the 5 domains, with 3 options possible in each domain: extreme problems, some/moderate problems, or no problems. Scores range from 0 to 1, with a score of 1 representing a perfect health state. (NCT00603239)
Timeframe: baseline and 26 weeks

Change in Impact of Weight on Quality of Life (IWQOL)-Lite Score

"IWQOL-Lite analysis of change from baseline to endpoint (26 weeks). IWQOL-Lite is a 31-item questionnaire, assessing the domains of physical function, self-esteem, sexual life, public distress, and work. Response categories for each item range from 1 = never true to 5 = always true." (NCT00603239)
Timeframe: baseline and 26 weeks

Hepatic Fat

The effect of exenatide and pioglitazone on liver fat content after one year of treatment in patients with type 2 diabetes. (NCT01432405)
Timeframe: one year

Plasma Adipocytokines

the effect of the intervention on plasma adiponectin levels. (NCT01432405)
Timeframe: one year

Mean Change From Baseline in Adiponectin at Week 26.

Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Mean Change From Baseline in Apolipoprotein B at Week 26

Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Mean Change From Baseline in Apolipoprotein B at Week 52

Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Mean Change From Baseline in Beta-cell Function at Week 26

"Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26.~Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B)." (NCT00700817)
Timeframe: Week 0, Week 26

Mean Change From Baseline in Beta-cell Function at Week 52

"Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52.~Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B)." (NCT00700817)
Timeframe: Week 0, Week 52

Mean Change From Baseline in Body Weight at Week 26

Calculated as an estimate of the mean change from baseline in body weight at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Mean Change From Baseline in Body Weight at Week 52

Calculated as an estimate of the mean change from baseline in body weight at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26

Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52

Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52

Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78

Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78. (NCT00700817)
Timeframe: Week 0, Week 78

Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26

Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52

Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26

Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52

Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78

Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78. (NCT00700817)
Timeframe: Week 0, Week 78

Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26

Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52

Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26

Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.

Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26

Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52

Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.

Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26

The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36. (NCT00700817)
Timeframe: Week 0, Week 26

Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52

The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36. (NCT00700817)
Timeframe: Week 0, Week 52

Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.

Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Mean Change From Baseline in Pulse at Week 26

Calculated as an estimate of the mean change from baseline in pulse at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Mean Change From Baseline in Pulse at Week 52

Calculated as an estimate of the mean change from baseline in pulse at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26

Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26 (NCT00700817)
Timeframe: Week 0, Week 26

Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52

Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Mean Change From Baseline in Total Cholesterol at Week 26

Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Mean Change From Baseline in Total Cholesterol at Week 52

Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Mean Change From Baseline in Triglycerides (TG) at Week 26

Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Mean Change From Baseline in Triglycerides (TG) at Week 52

Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.

Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26

Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52

Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.

Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26. vWf is a blood glycoprotein involved in haemostasis. (NCT00700817)
Timeframe: Week 0, Week 26

Mean Change From Baseline in Waist Circumference at Week 26.

Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26 (NCT00700817)
Timeframe: Week 0, Week 26

Mean Change From Baseline in Waist Circumference at Week 52

Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Mean Change From Baseline in Waist to Hip Ratio at Week 26.

Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26. The measure is assessed as the circumference of the waist divided by the circumference of the hip. (NCT00700817)
Timeframe: Week 0, Week 26

Mean Change From Baseline in Waist to Hip Ratio at Week 52

Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52. The measure is assessed as the circumference of the waist divided by the circumference of the hip. (NCT00700817)
Timeframe: Week 0, Week 52

Mean Change in Apolipoprotein B From Week 52 to Week 78

Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78

Mean Change in Beta-cell Function From Week 52 to Week 78

Mean change in beta-cell function from Week 52 to Week 78. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B). (NCT00700817)
Timeframe: Week 52, Week 78

Mean Change in Body Weight From Week 52 to Week 78

Mean change in body weight from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78

Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78

Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78

Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78

Mean change in fasting plasma glucose (FPG) Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78

Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78

Mean change in free fatty acids (FFA) from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78

Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78

Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78 (NCT00700817)
Timeframe: Week 52, Week 78

Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78

Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78

Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78

Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78

Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78

The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36. (NCT00700817)
Timeframe: Week 52, Week 78

Mean Change in Pulse From Week 52 to Week 78

Mean change in pulse from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78

Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78

Mean change in systolic blood pressure (SBP) from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78

Mean Change in Total Cholesterol From Week 52 to Week 78

Mean change in total cholesterol from Week 52 to Week 78 (NCT00700817)
Timeframe: Week 52, Week 78

Mean Change in Triglycerides (TG) From Week 52 to Week 78

Mean change in triglycerides (TG) from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78

Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78

Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78

Mean Change in Waist Circumference From Week 52 to Week 78

Mean change in Waist Circumference from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78

Mean Change in Waist to Hip Ratio From Week 52 to Week 78

Mean change in Waist to Hip Ratio from Week 52 to Week 78. The measure is assessed as the circumference of the waist divided by the circumference of the hip. (NCT00700817)
Timeframe: Week 52, Week 78

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26

Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26 (NCT00700817)
Timeframe: Week 0, Week 26

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 52 (NCT00700817)
Timeframe: Week 0, Week 52

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the extension 2 FAS. (NCT00700817)
Timeframe: Week 0, Week 78

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the FAS. (NCT00700817)
Timeframe: Week 0, Week 78

Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26

Calculated as the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 26 (NCT00700817)
Timeframe: Week 0, Week 26

Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 52 (NCT00700817)
Timeframe: Week 0, Week 52

Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the extension 2 FAS. (NCT00700817)
Timeframe: Week 0, Week 78

Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the FAS. (NCT00700817)
Timeframe: Week 0, Week 78

Hypoglycaamic Episodes, Weeks 52-78

Number of hypoglycaemic episodes from Week 52 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00700817)
Timeframe: Week 52-78

Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26

Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00700817)
Timeframe: Weeks 0-26

Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52

Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00700817)
Timeframe: Weeks 0-52

Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78

Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00700817)
Timeframe: Weeks 0-78

Hypoglyceamic Episodes, Weeks 0-26

Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00700817)
Timeframe: Weeks 0-26

Hypoglyceamic Episodes, Weeks 0-52

Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00700817)
Timeframe: Weeks 0-52

Hypoglyceamic Episodes, Weeks 0-78

Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00700817)
Timeframe: Weeks 0-78

Reviews

12 reviews available for metformin and Nausea

Trials

22 trials available for metformin and Nausea

Other Studies

7 other studies available for metformin and Nausea