metformin and Cholera Infantum

metformin has been researched along with Cholera Infantum in 44 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.

Research

Studies (44)

Authors

Clinical Trials (11)

Trial Overview

Trial Outcomes

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

Change in mean 7-point self-measured plasma glucose after 52 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Change From Baseline in BMI Standard Deviation Score (SDS)

Change in BMI SDS from baseline to week 52. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS)

Change in BMI SDS from baseline to week 26. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Change From Baseline in Body Weight

Change from baseline in body weight after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Change From Baseline in Body Weight

Change from baseline in body weight after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Change From Baseline in Fasting Plasma Glucose (FPG)

Change in FPG from baseline to week 26. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Change From Baseline in Height SDS

Change in height SDS from baseline to week 26. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Change From Baseline in Height SDS

Change in height SDS from baseline to week 52. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Change From Baseline in Pulse

Change from baseline in pulse 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Change From Baseline in Pulse

Change from baseline in pulse 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 104

Change in bone age from week 52 to week 104. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. (NCT01541215)
Timeframe: Week 52, week 104

Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 156

Change in bone age from week 52 to week 156. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. (NCT01541215)
Timeframe: Week 52, week 156

Change From Week 52 in Height SDS- Week 104

Change in height SDS from week 52 to week 104. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. (NCT01541215)
Timeframe: Week 52, week 104

Change From Week 52 in Height SDS- Week 156

Change in height SDS from week 52 to week 156. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. (NCT01541215)
Timeframe: Week 52, week 156

Change in Bone Age Assessment (X-ray of Left Hand and Wrist)

Change in bone age from baseline to week 52. If the baseline (week 0) bone age assessment indicated that all epiphyses were fused, then the assessment was not repeated at week 52. (NCT01541215)
Timeframe: Week 0, week 52

Change in FPG

Change in FPG from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Change in HbA1c

Change in HbA1c from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Change in HbA1c (Glycosylated Haemoglobin)

Change in HbA1c from baseline to week 26. All available data were used for the primary analysis, including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Change in Mean 7-point Self-measured Plasma Glucose

Change in mean 7-point self-measured plasma glucose after 26 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)

Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)

Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 52 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Growth (Height Velocity)

Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. (NCT01541215)
Timeframe: Week 0, week 26

Growth (Height Velocity)

Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. (NCT01541215)
Timeframe: Week 0, week 52

Growth (Height Velocity)- Week 104

Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. (NCT01541215)
Timeframe: Week 0, week 104

Growth (Height Velocity)- Week 156

Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. (NCT01541215)
Timeframe: Week 0, week 156

Height Velocity SDS

Height velocity SDS scores at week 26. Height velocity is change in height per year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Height Velocity SDS

Height velocity SDS scores at week 52. Height velocity is change in height per year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Height Velocity SDS- Week 104

The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. (NCT01541215)
Timeframe: Week 0, week 104

Height Velocity SDS- Week 156

The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. (NCT01541215)
Timeframe: Week 0, week 156

Number of Adverse Events (Week 0-26)

Total number of adverse events during 26 weeks. (NCT01541215)
Timeframe: 0-26 weeks

Number of Adverse Events (Week 0-52)

Total number of adverse events during entire treatment period. (NCT01541215)
Timeframe: 0-52 weeks

Number of Adverse Events (Week 53-104)

This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Number of adverse events reported during follow-up 1 (week 53 to 104). (NCT01541215)
Timeframe: Week 53-104

Number of Adverse Events (Week 53-156)

This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Number of adverse events reported during the follow-up period (weeks 53 to 156). (NCT01541215)
Timeframe: Week 53-156

Number of Hypoglycaemic Episodes

Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 26. (NCT01541215)
Timeframe: 0-26 weeks

Number of Hypoglycaemic Episodes

Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 52. (NCT01541215)
Timeframe: 0-52 weeks

Number of Serious Adverse Events (Week 0-26)

Total number of serious adverse events during 26 weeks. (NCT01541215)
Timeframe: 0-26 weeks

Number of Serious Adverse Events (Week 0-52)

Total number of serious adverse events during entire treatment period. (NCT01541215)
Timeframe: 0-52 weeks

Number of Serious Adverse Events (Week 53-104)

This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Number of serious adverse events reported during follow up 1 (week 53 to 104). (NCT01541215)
Timeframe: Weeks 53-104

Number of Serious Adverse Events (Week 53-156)

This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Number of serious adverse events reported during the follow up period (week 53 to 156). (NCT01541215)
Timeframe: Weeks 53-156

Number of Subjects Having HbA1c Below 7.0%

Percentage of subjects having HbA1c <7.0%. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 26

Ratio to Baseline: Fasting C-peptide

Ratio to baseline (fasting C-peptide) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Ratio to Baseline: Fasting C-peptide

Ratio to baseline (fasting C-peptide) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Ratio to Baseline: Fasting Glucagon

Ratio to baseline (fasting glucagon) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Ratio to Baseline: Fasting Glucagon

Ratio to baseline (fasting glucagon) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Ratio to Baseline: Fasting Insulin

Ratio to baseline (fasting insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Ratio to Baseline: Fasting Insulin

Ratio to baseline (fasting insulin) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Ratio to Baseline: Fasting Pro-insulin

Ratio to baseline (fasting pro-insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Ratio to Baseline: Fasting Pro-insulin

Ratio to baseline (fasting pro-insulin) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Ratio to Baseline: Free Fatty Acids

Ratio to baseline (free fatty acids) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Ratio to Baseline: Free Fatty Acids

Ratio to baseline (free fatty acids) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Ratio to Baseline: HDL Cholesterol

Ratio to baseline (HDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Ratio to Baseline: High-density Lipoprotein (HDL) Cholesterol

Ratio to baseline (HDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Ratio to Baseline: HOMA-B

Ratio to baseline (HOMA-B) after 52 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Ratio to Baseline: HOMA-IR

Ratio to baseline (HOMA-IR) after 52 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Ratio to Baseline: Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)

Ratio to baseline (HOMA-IR) after 26 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Ratio to Baseline: Homeostasis Model Assessment of Beta-cell Function (HOMA-B)

Ratio to baseline (HOMA-B) after 26 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Ratio to Baseline: LDL Cholesterol

Ratio to baseline (LDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Ratio to Baseline: Low Density Lipoprotein (LDL) Cholesterol

Ratio to baseline (LDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Ratio to Baseline: Pro-insulin/Insulin Ratio

Ratio to baseline (Pro-insulin/insulin ratio) after week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Ratio to Baseline: Pro-insulin/Insulin Ratio

Ratio to baseline (Pro-insulin/insulin ratio) after week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Ratio to Baseline: Total Cholesterol

Ratio to baseline (total cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Ratio to Baseline: Total Cholesterol

Ratio to baseline (total cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Ratio to Baseline: Triglycerides

Ratio to baseline (triglycerides) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Ratio to Baseline: Triglycerides

Ratio to baseline (triglycerides) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Ratio to Baseline: Very Low-density Lipoprotein (VLDL) Cholesterol

Ratio to baseline (VLDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Ratio to Baseline: VLDL Cholesterol

Ratio to baseline (VLDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

Change in blood pressure (systolic and diastolic blood pressure) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

Change in blood pressure (systolic and diastolic blood pressure) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)

Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)

Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 52 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Number of Subjects Having HbA1c Below 7.0%

Number of subjects achieving HbA1c <7.0% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 52

Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes

"Number of subjects achieving HbA1c <7.0% without severe or minor hypoglycaemic episodes after 26 weeks.~Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.~Minor hypoglycaemia was defined as meeting either of the below criteria:~an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself~any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication." (NCT01541215)
Timeframe: Week 26

Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes

"Number of subjects achieving HbA1c <7.0% without severe or minor hypoglycaemic episodes after 52 weeks.~Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.~Minor hypoglycaemia was defined as meeting either of the below criteria:~an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself~any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication." (NCT01541215)
Timeframe: Week 52

Number of Subjects Having HbA1c Below 7.5%

Number of subjects achieving HbA1c <7.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 26

Number of Subjects Having HbA1c Below 7.5%

Number of subjects achieving HbA1c <7.5% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 52

Number of Subjects Having HbA1c Maximum 6.5%

Number of subjects achieving HbA1c <=6.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 26

Number of Subjects Having HbA1c Maximum 6.5%

Number of subjects achieving HbA1c <=6.5% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 52

Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104

"Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents pre-adoloscent development and stage V represents pubertal development equivalent to that of an adult. The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of subjects at different Tanner stages at week 52 and week 104. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm." (NCT01541215)
Timeframe: Week 52, week 104

Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156

"Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents pre-adoloscent development and stage V represents pubertal development equivalent to that of an adult. The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of subjects at different Tanner stages at week 52 and week 156. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm." (NCT01541215)
Timeframe: Week 52, week 156

Pubertal Assessment/Progression (Tanner Staging)

Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V. The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of participants at different Tanner stages at week 0, week 26 and week 52. (NCT01541215)
Timeframe: Week 0, week 26, week 52

Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)

Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate. (NCT01075282)
Timeframe: Baseline, 52 weeks

Change From Baseline to 26 Weeks and 78 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)

Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate. (NCT01075282)
Timeframe: Baseline, 26 weeks, and 78 weeks

Change From Baseline to 26, 52 and 78 Weeks for Body Mass Index

Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Change From Baseline to 26, 52 and 78 Weeks for Body Weight

Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Change From Baseline to 26, 52 and 78 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles

The self-monitored blood glucose (SMBG) data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 3 AM or 5 hours after bedtime. Least Squares (LS) means of the mean of the 8 time points (Daily Mean) were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Change From Baseline to 26, 52 and 78 Weeks in the EuroQol 5 Dimension

The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part of the questionnaire consists of a 100-mm visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Activities of Daily Living

"The Impact of Weight on Activities of Daily Living questionnaire (renamed the Ability to Perform Physical Activities of Daily Living Questionnaire [APPADL]) contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = not at all difficult and 1 = unable to do. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate." (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Self-Perception

The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Change From Baseline to 26, 52 and 78 Weeks in the Low Blood Sugar Survey

The Low Blood Sugar Survey (LBSS) contains 33 items comprised of 2 subscales (behavior and worry), each of which is rated on a 5-point numeric rating scale from 0 (never) to 4 (almost always). It captures behavioral changes associated with the concerns and experiences of hypoglycemia and the degree to which participants are worried about certain aspects associated with hypoglycemia during the previous 4 weeks. The behavior (or avoidance) subscale has 15 items, and the worry (or affect) subscale has 18 items. Subscale scores are calculated by summing participant responses to items (behavior range 0-60; worry range 0-72). A total score is calculated as the sum of both subscales (range 0-132). Higher scores indicate greater negative impact on subscales and total score. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval

The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Heart Rate

Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Change From Baseline to 26, 52 and 78 Weeks on Pancreatic Enzymes

Amylase (total and pancreas-derived) and lipase concentrations were measured. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Change From Baseline to 26, 52 and 78 Weeks on Serum Calcitonin

(NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Change From Baseline to 26, 52, and 78 Weeks on Blood Pressure

Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Change From Baseline to 52 and 78 Weeks in Glucagon Concentration

Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 52, and 78 weeks

Change From Baseline to 52 and 78 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)

The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population for both HOMA2-B and HOMA-2S were set at 100%. Least Squares (LS) means of change from baseline of C-peptide based HOMA2-%B and HOMA2-%S were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 52, and 78 weeks

Change in Baseline to 26, 52 and 78 Weeks on Pulse Rate

Sitting pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% at 26, 52 and 78 Weeks

Number of participants achieving HbA1c levels less than 7.0% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model. (NCT01075282)
Timeframe: 26, 52, and 78 weeks

Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than or Equal to 6.5% at 26, 52 and 78 Weeks

Number of participants achieving HbA1c levels less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model. (NCT01075282)
Timeframe: 26, 52, and 78 weeks

Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26, 52 and 78 Weeks

Additional intervention was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. The number of participants requiring additional intervention due to hyperglycemia is summarized cumulatively at 26, 52, and 78 weeks. (NCT01075282)
Timeframe: 26, 52, and 78 weeks

Number of Participants With Adjudicated Cardiovascular Events at 26, 52 and 78 Weeks

Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new CV event was prospectively collected using a CV event electronic case report form. At prespecified visits, participants were asked about any new CV event. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with adjudicated CV events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01075282)
Timeframe: Baseline through 26, 52, and 78 weeks

Number of Participants With Adjudicated Pancreatitis at 26, 52 and 78 Weeks

The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01075282)
Timeframe: Baseline through 26, 52, and 78 weeks

Number of Participants With LY2189265 Antibodies at 26, 52, 78 Weeks and 4 Weeks After Last Dose of Study Drug (83 Weeks Maximum)

LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed at baseline, 26, 52, and 78 weeks, and at the safety follow-up visit 30 days after study drug discontinuation (83 weeks). The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA at each time point were summarized. (NCT01075282)
Timeframe: Baseline, 26, 52, 78, and 83 weeks

Number of Participants With Treatment Emergent Adverse Events at 26, 52 and 78 Weeks

A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01075282)
Timeframe: 26, 52, and 78 weeks

Number of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks

Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01075282)
Timeframe: Baseline through 26, 52, and 78 weeks

Rate of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks

Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01075282)
Timeframe: Baseline through 26, 52, and 78 weeks

Change in Body Composition

Change in percent body fat (NCT01881828)
Timeframe: 0-26 weeks

Change in Body Mass Index (BMI)

(NCT01881828)
Timeframe: 0-26 weeks

Change in Total Daily Dose of Insulin (TDI) Per kg

(NCT01881828)
Timeframe: 0-26 weeks

Change in Waist Circumference

(NCT01881828)
Timeframe: 0-26 weeks

Change in Blood Pressure

(NCT01881828)
Timeframe: 0-26 weeks

Change in Hemoglobin A1c From Baseline to 26 Weeks, Adjusted for Baseline Hemoglobin A1c.

Hemoglobin A1c is a measure of glycemic control over approximately the past 3 months (NCT01881828)
Timeframe: 0-26 weeks

Change in Hemoglobin A1c From Baseline to 26 Weeks, Adjusted for Baseline Hemoglobin A1c.

Hemoglobin A1c is a measure of glycemic control over approximately the past 3 months (NCT01881828)
Timeframe: 0-26 weeks

Change in Serum Lipids

(NCT01881828)
Timeframe: 0-26 weeks

Concentration of Metformin in Adipose Tissue

To determine the concentration of metformin in adipose tissue. (NCT03477162)
Timeframe: Within 7 days from surgery

Concentration of Metformin in Plasma.

To determine the concentration of metformin in plasma. (NCT03477162)
Timeframe: Within 7 days from surgery

Concentration of Metformin in Tumor-adjacent Normal Tissue

To determine the concentration of metformin in tumor-adjacent normal tissue. (NCT03477162)
Timeframe: Within 7 days from surgery

Concentration of Metformin in Whole Blood.

To determine the concentration of metformin in whole blood. (NCT03477162)
Timeframe: Within 7 days from surgery

Lung Tumor Tissue Concentration of Metformin

To determine the intra-tumor concentrations of metformin, with a standard deviation ≤25% of the mean, in patients with solid tumors of thoracic origin administered metformin extended release. (NCT03477162)
Timeframe: Within 7 days from surgery

Reviews

9 reviews available for metformin and Cholera Infantum

Trials

17 trials available for metformin and Cholera Infantum

Other Studies

18 other studies available for metformin and Cholera Infantum