pioglitazone and Fasting Hypoglycemia

pioglitazone has been researched along with Fasting Hypoglycemia in 55 studies

Pioglitazone: A thiazolidinedione and PPAR GAMMA agonist that is used in the treatment of TYPE 2 DIABETES MELLITUS.
pioglitazone : A member of the class of thiazolidenediones that is 1,3-thiazolidine-2,4-dione substituted by a benzyl group at position 5 which in turn is substituted by a 2-(5-ethylpyridin-2-yl)ethoxy group at position 4 of the phenyl ring. It exhibits hypoglycemic activity.

Fasting Hypoglycemia: HYPOGLYCEMIA expressed in the postabsorptive state, after prolonged FASTING, or an overnight fast.

Research

Studies (55)

Authors

Clinical Trials (30)

Trial Overview

Trial Outcomes

Acute/Active Rejection

Grades IA through III and antibody immediate rejection, either A (immediate or hyperacute) or B (delayed or accelerated acute) were diagnosed and classified based on renal allograft biopsies according to the Banff 97 Working Classification of Renal Allograph Pathology. (NCT00609986)
Timeframe: 30 months

Delayed Graft Function

Need for dialysis in the first week post-transplant in a patient who required dialysis pre-transplantation or day-10 post-transplant creatinine concentration above 2.5 mg/dl. (NCT00609986)
Timeframe: 10 days

Severe Hyperglycemia

Blood glucose greater than 350 mg/dl. (NCT00609986)
Timeframe: 30 months

Severe Hypoglycemia

Blood glucose less than 40 mg/dl (NCT00609986)
Timeframe: 30 months

Incidence of Poor Graft Function After Kidney Transplant

Our primary endpoint will be poor initial graft function defined by the occurrence of DGF (defined by a decrease in serum creatinine of <10%/day for 3 consecutive days after transplant) or slow graft function (serum creatinine >3 mg/dL 5 days after transplant without dialysis) (NCT01643382)
Timeframe: 7 days after transplant

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 time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required. (NCT00763815)
Timeframe: Baseline, Week 24

Change From Baseline in Beta-cell Function Assessed by Homeostasis Model Assessment for Beta-cell Function (HOMA-beta) at Week 24

Beta cell function was assessed by HOMA-beta. HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin [micro unit per milliliter]) divided by (fasting plasma glucose [mmol/L] minus 3.5). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required. (NCT00763815)
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 time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required. (NCT00763815)
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 time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required. (NCT00763815)
Timeframe: Baseline, Week 24

Change From Baseline in Fasting Plasma Insulin (FPI) at Week 24

Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required. (NCT00763815)
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 >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 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 assessment for at least 1 efficacy variable, were required. (NCT00763815)
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 time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required. (NCT00763815)
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 assessment for at least 1 efficacy variable, were required. (NCT00763815)
Timeframe: Week 24

Percentage of Patients With 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 assessment for at least 1 efficacy variable, were required. (NCT00763815)
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. (NCT00763815)
Timeframe: First dose of study drug up to 3 days after the last dose administration, for up to 132 weeks

Change From Baseline in 2-Hour PMG at Week 54

PMG was measured using the Meal Tolerance Test (MTT). (NCT00722371)
Timeframe: Baseline and Week 54

Change From Baseline in 2-Hour Post-meal Glucose (PMG) at Week 24

PMG was measured using the Meal Tolerance Test (MTT). (NCT00722371)
Timeframe: Baseline and Week 24

Change From Baseline in A1C at Week 54

A1C represents the percentage of glycosylated hemoglobin. (NCT00722371)
Timeframe: Baseline and Week 54

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

(NCT00722371)
Timeframe: Baseline and Week 24

Change From Baseline in FPG at Week 54

(NCT00722371)
Timeframe: Baseline and Week 54

Change From Baseline in Hemoglobin A1C (A1C) at Week 24

A1C represents the percentage of glycosylated hemoglobin. (NCT00722371)
Timeframe: Baseline and Week 24

Change in HbA1c From Baseline to 24 Weeks Endpoint (Intention-to-Treat Population)

The change from baseline to 24 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects. (NCT01175824)
Timeframe: Baseline, 24 weeks

Change in HbA1c From Baseline to 24 Weeks Endpoint (Per Protocol Population)

The change from baseline to 24 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects. (NCT01175824)
Timeframe: Baseline, 24 weeks

Change in the HbA1c Concentration From Baseline to 12 Weeks Endpoint

The change from baseline to 12 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects. (NCT01175824)
Timeframe: Baseline, 12 weeks

Insulin Treatment Satisfaction Questionnaire (ITSQ) Score at 24 Weeks

ITSQ: validated instrument containing 22 items which are measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother) used to assess insulin treatment satisfaction. Items are divided into 5 domains: Inconvenience of Regimen (5 items: domain score range 5 to 35), Lifestyle Flexibility (3 items: domain score range 3 to 21), Glycemic Control (3 items: domain score range 3 to 21), Hypoglycemic Control (5 items: domain score range 5 to 35), Insulin Delivery Device (6 items: domain score range 6 to 42) lower scores reflect better outcome. ITSQ Total Overall Score ranged from 22 to 154. Raw domain scores transformed on 0-100 scale, where transformed domain score = 100×[(7-raw domain score)/6]. Higher scores indicate better treatment satisfaction. Least squares (LS) mean estimated from analysis of covariance (ANCOVA) model that included baseline score as covariate and treatment, glycosylated hemoglobin A1c (HbA1c) stratum, and country as fixed effects. (NCT01175824)
Timeframe: 24 weeks

The Number of Participants With a Hypoglycemic Episodes (Incidence)

A hypoglycemic episode was defined as an event associated with 1) reported signs and symptoms of hypoglycemia, and/or 2) a documented blood glucose (BG) concentration of <= 70 milligrams per deciliter [mg/dL, 3.9 millimoles per liter (mmol/L)]. (NCT01175824)
Timeframe: Baseline through 24 weeks

The Number of Participants With Severe Hypoglycemic Episodes

The number of participants who had a severe hypoglycemic episode anytime during the study. Severe hypoglycemia was defined as any event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. (NCT01175824)
Timeframe: Baseline through 24 weeks

The Rate of Hypoglycemic Episodes

The hypoglycemia rate per 30 days was calculated as the number of episodes reported for the interval between visits and during the study divided by the number of days in the given interval and multiplied by 30. (NCT01175824)
Timeframe: Baseline through 24 weeks

7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks

7-point Self-monitored Blood Glucose (SMBG) Profiles are measures of blood glucose taken 7 times a day at the morning pre-meal, morning 2-hours post-meal, midday pre-meal, midday 2-hours post-meal, evening pre-meal, evening 2-hours post-meal, and 0300 hour [3 am]. Each participant took measures on 3 non-consecutive days and the average was calculated for each of the 7 time points. The mean of the 7-point averages was calculated for all the participants at baseline, Weeks 12 and 24. The least squares (LS) mean was estimated from mixed-effects model with repeated measures that included the baseline value of the variable as a covariate, treatment, country, baseline glycosylated hemoglobin A1c (HbA1c)stratification level, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects. (NCT01175824)
Timeframe: 12 weeks, 24 weeks

Change in the Fasting Plasma Glucose Concentration From Baseline to 12 Weeks and 24 Weeks

The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline fasting plasma glucose value as a covariate, treatment, country, baseline HbA1c stratification level, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects. (NCT01175824)
Timeframe: Baseline, 12 weeks, and 24 weeks

Change in Weight From Baseline to 12 Weeks and 24 Weeks

The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline weight as a covariate, treatment, country, baseline glycosylated hemoglobin A1c (HbA1c) stratification level, week of visit, and the treatment-by-week interaction as fixed effects, and participant and error as random effects. (NCT01175824)
Timeframe: Baseline, 12 weeks, 24 weeks

Daily Insulin Dose: Total, Basal, and Prandial at 12 Weeks and 24 Weeks

(NCT01175824)
Timeframe: 12 weeks, 24 weeks

Glycemic Variability From the 7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks

The 7-point SMBG profile was calculated as the average blood glucose concentration across the 7 pre-specified time points in a day that was then averaged over 3 non-consecutive days in the 2 weeks prior to the 12 week visit and 24 week visit. Glycemic variability was calculated as the standard deviation of the 7-point SMBG profiles. Standard deviation was first calculated for each day and then averaged over 3 non-consecutive days for each visit. The least squares (LS) mean was estimated from mixed-effects model with repeated measures that included the baseline value of the variable as a covariate, treatment, country, baseline glycosylated hemoglobin A1c (HbA1c)stratification level, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects. (NCT01175824)
Timeframe: 12 weeks, 24 weeks

Number of Participants Who Achieve a Target HbA1c Concentration of Less Than 7% or Less Than or Equal to 6.5% at 24 Weeks

(NCT01175824)
Timeframe: 24 weeks

Perceptions About Medications-Diabetes 21 (PAM-D21) Questionnaire Score at 24 Weeks

PAM-D21 is a validated questionnaire consisting of 21 items to assess a participant's perceptions about their diabetes treatment regimens and perceived emotional and physical side-effects. The PAM-D21 consists of 4 subscales: Convenience/Flexibility (items 1 to 3); Perceived Effectiveness (items 4 to 6); Emotional Effects (items 7 to 11); and Physical Effects (items 12 to 21). Item scores range from 1 (none of the time) to 4 (all of the time). Subscale scores were linearly transformed to a 0-100, with higher score corresponds to better perceptions about diabetes medications. The least squares (LS) mean was estimated from an analysis of covariance (ANCOVA) model that included baseline score as a covariate and treatment, glycosylated hemoglobin A1c (HbA1c) stratum, and country as fixed effects. (NCT01175824)
Timeframe: 24 weeks

Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks

Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 12 (NCT00996658)
Timeframe: baseline, 12 weeks

Change From Baseline in Fasting Plasma Glucose (FPG) After 18 Weeks

Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 18 (NCT00996658)
Timeframe: baseline, 18 weeks

Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks

Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 24 (NCT00996658)
Timeframe: baseline, 24 weeks

Change From Baseline in Fasting Plasma Glucose (FPG) After 6 Weeks

Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 6 (NCT00996658)
Timeframe: baseline, 6 weeks

Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks

Glycosylated hemoglobin is reported as a percentage of the total hemoglobin (NCT00996658)
Timeframe: baseline, 12 weeks

Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks

Glycosylated hemoglobin is reported as a percentage of the total hemoglobin (NCT00996658)
Timeframe: baseline, 18 weeks

Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks

Glycosylated hemoglobin is reported as a percentage of the total hemoglobin (NCT00996658)
Timeframe: baseline, 24 weeks

Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks

Glycosylated hemoglobin is reported as a percentage of the total hemoglobin (NCT00996658)
Timeframe: baseline, 6 weeks

Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks

Glycosylated hemoglobin is reported as a percentage of the total hemoglobin (NCT00996658)
Timeframe: 24 weeks

Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks

Glycosylated hemoglobin is reported as a percentage of the total hemoglobin (NCT00996658)
Timeframe: 24 weeks

Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks

Glycosylated hemoglobin is reported as a percentage of the total hemoglobin (NCT00996658)
Timeframe: 24 weeks

Change From Baseline (Week 0) in Glycosylated Hemoglobin (HbA1c) (%) at Week 12

Fasted blood samples for HbA1c were collected at Baseline and Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Only those participants with a value at Baseline and at Week 12 (after Last Observation Carried Forward [LOCF]) were used for this analysis. Adjusted mean is presented as least square mean. (NCT00500331)
Timeframe: Baseline (Week 0) and Week 12

Change From Baseline in 24-hour Percent of Filtered Glucose Excreted in Urine

A 24-hour urine collection was obtained from all participants at Baseline (Week 0) and Week 12 to measure glucose. Participants were provided with urine collection bottles and cooler prior to these visits and instructed that the urine collections must be kept cold and dropped off at the clinic prior to or at the scheduled visits. Site staff queried participants to determine whether the sample represented a full 24-hour collection. The total volume and the sample date and time were recorded. The entire 24-hour urine collection was well mixed in one container and a urine aliquot obtained. Samples were assayed for glucose. The 24-hour collections were used to derive 24-hour urine glucose excretion corrected for filtered load. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. (NCT00500331)
Timeframe: Baseline (Week 0) and Week 12 (24-hour urine collection)

Change From Baseline in C-peptide AUC During a 2-hr OGTT

"Post-prandial assessments of C-peptide were performed at Baseline (Week 0) and at Week 12 using a 2-hour OGTT in a subgroup of participants at selected sites who agreed to participate. Participants were required to fast for at least 8 hours prior to the test. Seventy-five (75) g of standard oral glucose solution was administered 15 minutes after the morning administration of study medication (Week 12) and in the place of breakfast at Week 0 (i.e., at Week 0 the OGTT was completed prior to administration of study medication). Time 0 started when the participants drank the glucose solution. Blood samples were collected at the following times relative to the administration of oral glucose: -30 min (pre-glucose), -20 min (pre-glucose), 20 min, 30 min, 1 hour, 1.5 hour and 2 hour post glucose administration. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values." (NCT00500331)
Timeframe: Baseline (Week 0) and Week 12 (0 to 2 hour OGTT)

Change From Baseline in Insulin AUC During a 2-hour OGTT

"Post-prandial assessments of insulin were performed at Baseline (Week 0) and at Week 12 using a 2-hour OGTT in a subgroup of participants at selected sites who agreed to participate. Participants were required to fast for at least 8 hours prior to the test. Seventy-five (75) g of standard oral glucose solution was administered 15 minutes after the morning administration of study medication (Week 12) and in the place of breakfast at Week 0 (i.e., at Week 0 the OGTT was completed prior to administration of study medication). Time 0 started when the participants drank the glucose solution. Blood samples were collected at the following times relative to the administration of oral glucose: -30 min (pre-glucose), -20 min (pre-glucose), 20 min, 30 min, 1 hour, 1.5 hour and 2 hour post glucose administration. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values." (NCT00500331)
Timeframe: Baseline (Week 0) and Week 12 (0 to 2-hour OGTT)

Change From Baseline in Plasma Glucose Area Under the Curve (AUC) During a 2-hour Oral Glucose Tolerance Test (OGTT)

"Post-prandial assessments of glucose were performed at Baseline (Week 0) and at Week 12 using a 2-hour OGTT in a subgroup of participants at selected sites who agreed to participate. Participants were required to fast for at least 8 hours prior to the test. Seventy-five (75) g of standard oral glucose solution was administered 15 minutes after the morning administration of study medication (Week 12) and in the place of breakfast at Week 0 (i.e., at Week 0 the OGTT was completed prior to administration of study medication). Time 0 started when the participants drank the glucose solution. Blood samples were collected at the following times relative to the administration of oral glucose: -30 min (pre-glucose), -20 min (pre-glucose), 20 min, 30 min, 1 hour, 1.5 hour and 2 hour post glucose administration. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values." (NCT00500331)
Timeframe: Baseline (Week 0) and Week 12 (0 to 2 hour OGTT)

Change From Baseline to Week 12 in Body Weight

Weight of participants was measured from Baseline (Week 0) to Week 12 and recorded in the case report form (CRF). Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. (NCT00500331)
Timeframe: Baseline (Week 0) to Week 12

Change From Baseline to Week 12 in Fasting Insulin

Fasted blood samples for insulin were collected up to Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. (NCT00500331)
Timeframe: Baseline (Week 0) to Week 12

Change From Baseline to Week 12 in Fructosamine

Fasted blood samples for fructosamine were collected up to Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. (NCT00500331)
Timeframe: Baseline (Week 0) to Week 12

Change From Baseline to Week 12 in Waist Circumference

Waist circumference of participants was measured from Baseline (Week 0) to Week 12 and recorded in the CRF. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. (NCT00500331)
Timeframe: Baseline (Week 0) to Week 12

Number of Participants With On-therapy Hypoglycemia

Hypoglycemia is low blood glucose or low blood sugar. Hypoglycemic events were collected separately and reported separately from AE, including supplemental data which were not collected for AE. However, any hypoglycemic event which met the criteria for a SAE was included in the SAE summaries. The number of participants in each group that experienced a hypoglycemic event was summarized by frequency of the events. (NCT00500331)
Timeframe: Up to 14 weeks

Change From Baseline in HbA1c (%) at Weeks 4 and 8

Fasted blood samples for HbA1c were collected at Baseline and Weeks 4 and 8. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. (NCT00500331)
Timeframe: Baseline (Week 0) and Week 4 and Week 8

Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12

Fasted blood samples for FPG were collected up to Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. (NCT00500331)
Timeframe: Baseline (Week 0) and Week 4, Week 8 and Week 12

Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L

Fasted blood samples for HbA1c were collected at Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Number of participants at Week 12 with: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 mmo/L (126 milligram/deciliter [mg/dL]), FPG <7.8 mmol/L (140 mg/dL); FPG <5.5 mmol/L (100 mg/dL); a decrease from Baseline of HbA1c >= 0.7%; a decrease from Baseline of FPG ≥1.7 mmol/L (30 mg/dL) are presented. (NCT00500331)
Timeframe: Week 12

Number of Participants With Change From Baseline in Standard Laboratory Parameters of Potential Clinical Concern

Participants were instructed to fast for at least 8 hours prior to all study visits for the collection of laboratory samples. An additional fasting blood sample (serum and plasma) was drawn at Week 0, Week 4, Week 6 and Week 12 or at early withdrawal (up to 14 weeks) and kept in long-term storage for future testing of biomarkers for diabetes and complications of the disease. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. (NCT00500331)
Timeframe: Up to 14 weeks

Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern

Vital signs included heart rate and blood pressure. Heart rate and blood pressure were taken before blood draws were performed. Participants were asked to refrain from smoking for at least 30 minutes prior to vital sign measurements. Heart rate and blood pressure was measured pre-dose in duplicate at the specified visits, after the participant had been lying quietly for 5 minutes, and then in duplicate 3 minutes after standing up. Heart rate was measured at the same time as blood pressure using the standardized blood pressure equipment that was provided. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. (NCT00500331)
Timeframe: Up to 14 weeks

Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern

Full 12-lead ECGs were recorded at screening, Baseline (Week 0), Week 4, Week 12 or early withdrawal, and Week 14 (Follow-up) using an ECG machine that automatically calculated the heart rate and measured the PR, QRS, QT and corrected QT (QTc) intervals. All 12-lead ECGs were read locally by the Investigator or his/her designate and were forwarded electronically to the central reader for interpretation. If the QTc was >500 milliseconds (msec) on the locally read ECG recording, an additional 2 ECG recordings at 10 minute intervals were made at that visit. If the average QTc for the 3 recordings was >500 msec, the participant was withdrawn from the study. (NCT00500331)
Timeframe: Up to Early withdrawal (Between Week 12 and Week 14)

Number of Participants With On-therapy Adverse Events (AE) and Serious Adverse Events (SAE)

AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. (NCT00500331)
Timeframe: Up to 12 weeks

Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C])

Fasted samples for TC, LDL-C, HDL-C and TG were collected at Week 12. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Percent Change based on log-transformed data: 100*(exponentiated(mean change on log scale)-1) (NCT00500331)
Timeframe: Baseline (Week 0) and Week 4, Week 8 and Week 12

Change in BMI

Change in BMI (body mass index) from study start to 16 weeks (NCT02613897)
Timeframe: Change from baseline to 16 weeks

Change in Body Weight

Change in body weight from baseline to 16 weeks (NCT02613897)
Timeframe: Baseline to 16 weeks

Change in Fasting Plasma Glucagon (FPG)

A measure of the change in fasting plasma glucagon from study start to 16 weeks (NCT02613897)
Timeframe: Change from baseline to 16 weeks

Change in Free Fatty Acids (FFA)

Measure of change in Free Fatty Acids from study start to 16 weeks (NCT02613897)
Timeframe: Change from baseline to 16 weeks

Change in Glucose Oxidation

Change in percentage of glucose oxidation from study start to 16 weeks (NCT02613897)
Timeframe: Change from baseline to 16 weeks

Change in Lipid Oxidation

Change in lipid oxidation percentage from baseline to 16 weeks (NCT02613897)
Timeframe: Change from baseline to 16 weeks

HBA1c

Change in blood glucose level measured over a 3 month period from study start to 16 weeks (NCT02613897)
Timeframe: Change from baseline to 16 weeks

Mean Oral Glucose Tolerance Test (OGTT)

Measure of change in OGTT from study start to 16 weeks (NCT02613897)
Timeframe: Change from baseline to 16 weeks

Change in Endogenous Glucose Production (EGP)

All subjects received a Double-Tracer Oral Glucose Tolerance Test (OGTT) with 75g of glucose containing 14C-glucose together with intravenous primed-continuous infusion of 3(3H)-glucose for 240 minutes, at baseline (prior to) and after 16 weeks of therapy. Blood and urine samples were obtained during the OGTT to determine EGP. (NCT02613897)
Timeframe: Baseline and 16 weeks

Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test

Values of mean change in normalised iAUC0-4h values based on LOCF data derived from the glucose concentration profiles during a meal test. The meal test was performed at selected sites at baseline and after 26 weeks of treatment in the main trial period. The incremental AUC was calculated using the trapezoidal method and the resulting area was divided length of the observation period to yield the (normalised) prandial increment in mmol/L using the available valid glucose observations and the associated actual elapsed time point. (NCT01336023)
Timeframe: Week 0, Week 26

Mean Actual Daily Insulin Dose

Mean of the actual doses recorded at visit 28 (Week 26). (NCT01336023)
Timeframe: Week 26

Mean Change From Baseline in Body Weight at Week 26

Values of mean change in body weight. (NCT01336023)
Timeframe: Week 0, Week 26

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

Values of mean change in HbA1c. (NCT01336023)
Timeframe: Week 0, week 26

Number of Hypoglycaemic Episodes

Reported hypoglycemaic episodes are number of hypoglycemic events per 100 patient years of exposure. (NCT01336023)
Timeframe: Weeks 0-26

Percentage of Participants Achieving A1c <7% at Week 24

Percentage of participants achieving A1C < 7%, the American Diabetic Association's defined goal for glycemia, at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24. (NCT00295633)
Timeframe: Week 24

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

Mean change from baseline in FPG at Week 24, adjusted for baseline value. (NCT00295633)
Timeframe: Baseline, Week 24

Change From Baseline in Hemoglobin A1c (A1C) at Week 24

Mean change from baseline in A1C at Week 24, adjusted for baseline value. (NCT00295633)
Timeframe: Baseline, Week 24

Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24

Mean change from baseline for 0 to 180 minutes PPG AUC achieved at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24, adjusted for baseline value. (NCT00295633)
Timeframe: Baseline, Week 24

Alanine Aminotransferase (ALT) at Week 12.

The ALT hepatic transaminase levels are going to be measured at week 12 with standardized techniques. (NCT02113241)
Timeframe: Week 12.

Aspartate Aminotransferase (AST) at Week 12.

The hepatic transaminase AST will be evaluated with standardized methods at week 12 (NCT02113241)
Timeframe: Week 12

AUC of Glucose at Week 12.

The AUC of glucose will be calculated from the glucose values obtained from the minuted oral glucose tolerance curve at week 12 (NCT02113241)
Timeframe: Week 12

AUC of Insulin at Week 12.

The AUC will be calculated from the insulin values obtained from the minuted oral glucose tolerance curve at week 12 (NCT02113241)
Timeframe: Week 12

Body Mass Index at Week 12

The Body Mass index it's going to be calculated at week 12 with the Quetelet index. (NCT02113241)
Timeframe: Week 12

Body Weight at Week 12.

The weight it's going to be measured at week 12 with a bioimpedance balance. (NCT02113241)
Timeframe: Week 12

Creatinine at Week 12.

The creatinine levels are going to be measured at week 12 with standardized techniques. (NCT02113241)
Timeframe: Week 12.

Diastolic Blood Pressure at Week 12.

The diastolic blood pressure is going to be evaluated at week 12 with a digital sphygmomanometer. (NCT02113241)
Timeframe: Week 12

Fat Mass at Week 12.

The fat mass is going to be evaluated at week 12 through bioimpedance. (NCT02113241)
Timeframe: Week 12

Glucose at Minute 120 at Week 12.

The glucose at minute 120 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve (NCT02113241)
Timeframe: Week 12

Glucose at Minute 30 at Week 12.

The glucose at minute 30 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve (NCT02113241)
Timeframe: Week 12

Glucose at Minute 60 at Week 12.

The glucose at minute 60 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve (NCT02113241)
Timeframe: Week 12

Glucose at Minute 90 at Week 12.

The glucose at minute 90 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve (NCT02113241)
Timeframe: Week 12

Glucose Levels at Minute 0 at Week 12.

The fasting glucose (0') levels are going to be evaluated at week 12 with enzymatic/colorimetric techniques. (NCT02113241)
Timeframe: Week 12

High Density Lipoprotein (c-HDL) Levels at Week 12.

The c-HDL levels are going to be evaluated at week 12 with enzymatic/colorimetric techniques. (NCT02113241)
Timeframe: Week 12

Insulinogenic Index (Total Insulin Secretion) at Week 12.

"The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus.~Total insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion at week 12." (NCT02113241)
Timeframe: Week 12

Low Density Lipoproteins (c-LDL) at Week 12

The c-LDL levels are going to be measured at week 12 with standardized techniques. (NCT02113241)
Timeframe: Week 12

Matsuda Index (Total Insulin Sensitivity) at Week 12.

Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity at week 12. (NCT02113241)
Timeframe: Week 12

Stumvoll Index (First Phase of Insulin Secretion) at Week 12.

"Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis.~First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the frst phase of insulin secretion at week 12." (NCT02113241)
Timeframe: Week 12

Systolic Blood Pressure at Week 12.

The systolic blood pressure is going to be evaluated at week 12 with a digital sphygmomanometer. (NCT02113241)
Timeframe: Week 12

Total Cholesterol at Week 12

The total cholesterol will be estimated by standardized techniques at week 12. (NCT02113241)
Timeframe: Week 12

Triglycerides Levels at Week 12.

The triglycerides levels are going to be evaluated at week 12 with enzymatic-colorimetric techniques. (NCT02113241)
Timeframe: Week 12

Uric Acid at Week 12.

The uric acid levels are going to be measured at week 12 with standardized techniques. (NCT02113241)
Timeframe: Week 12.

Waist Circumference at Week 12.

The waist circumference is going to be evaluated at week 12 with a flexible tape with standardized techniques. (NCT02113241)
Timeframe: Week 12

Adjusted Mean Change From Baseline in 120-minute Post-challenge Plasma Glucose (PPG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. In post oral glucose tolerance test (OGTT), glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained on Day 1 and week 24 in the double-blind period. (NCT00683878)
Timeframe: From Baseline to Week 24

Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double-blind period. (NCT00683878)
Timeframe: From Baseline to Week 24

Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])

HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period. (NCT00683878)
Timeframe: From Baseline to Week 24

Adjusted Mean Change From Baseline in Total Body Weight (kg) Among Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight among subjects with baseline body mass index (BMI) ≥ 27 kg/m^2 at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period. (NCT00683878)
Timeframe: From Baseline to Week 24

Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period. (NCT00683878)
Timeframe: From Baseline to Week 24

Adjusted Mean Change From Baseline in Waist Circumference (cm) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in waist circumference at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Waist circumference measurements were obtained during the qualification and lead-in periods and on Day 1 and Week 24 of the double-blind period. (NCT00683878)
Timeframe: From Baseline to Week 24

Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Mean and standard error for percentage of participants were estimated by modified logistic regression model. (NCT00683878)
Timeframe: From Baseline to Week 24

Reviews

16 reviews available for pioglitazone and Fasting Hypoglycemia

Trials

20 trials available for pioglitazone and Fasting Hypoglycemia

Other Studies

19 other studies available for pioglitazone and Fasting Hypoglycemia