metformin and Genital Diseases, Female

metformin has been researched along with Genital Diseases, Female in 3 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.

Genital Diseases, Female: Pathological processes involving the female reproductive tract (GENITALIA, FEMALE).

Research

Studies (3)

Authors

Clinical Trials (3)

Trial Overview

Trial Outcomes

Adjusted Mean Change in Body Weight

To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing body weight or causing less weight gain as compared to placebo added to insulin treatment after 24 weeks of treatment (LOCF), excluding data after insulin up-titration. (NCT00673231)
Timeframe: Baseline to Week 24

Adjusted Mean Change in Calculated Mean Daily Insulin Dose

To examine whether treatment with dapagliflozin in combination with insulin leads to a lower absolute calculated mean daily insulin dose as compared to placebo added to insulin treatment alone, from baseline to week 24, including data after insulin up-titration. (NCT00673231)
Timeframe: Baseline to Week 24

Adjusted Mean Change in Fasting Plasma Glucose (FPG)

To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing Fasting Plasma Glucose (FPG) as compared to placebo added to insulin treatment after 24 weeks of treatment, excluding data after insulin up-titration. (NCT00673231)
Timeframe: Baseline to Week 24

Adjusted Mean Change in HbA1c Levels

To assess the efficacy of 2.5 mg, 5 mg and 10 mg dapagliflozin compared to placebo as add-on therapy to insulin in improving glycaemic control in participants with type 2 diabetes who have inadequate glycaemic control on ≥ 30 IU injectable insulin daily for at least 8 weeks prior to enrolment, as determined by the change in HbA1c levels from baseline to Week 24, excluding data after insulin up-titration. (NCT00673231)
Timeframe: Baseline to Week 24

Proportion of Participants With Calculated Mean Daily Insulin Dose Reduction

To examine whether treatment with dapagliflozin in combination with insulin leads to higher percentage of participants with calculated mean daily insulin dose reduction from baseline to week 24 (i.e. reduction >= 10%) as compared to placebo added to insulin treatment. (NCT00673231)
Timeframe: Baseline to Week 24

Proportion of Participants With Lack of Glycemic Control

Participants with lack of glycemic control or insulin up-titration for failing to achieve pre-specified glycemic targets (NCT00673231)
Timeframe: Baseline to Week 24

Baseline Body Weight

(NCT01059825)
Timeframe: Baseline

Baseline Diastolic Blood Pressure

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. (NCT01059825)
Timeframe: Baseline

Baseline Fasting Plasma Glucose

Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Baseline

Baseline Hemoglobin A1c (HbA1c)

HbA1c is measured as percent. (NCT01059825)
Timeframe: Baseline

Baseline Systolic Blood Pressure

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. (NCT01059825)
Timeframe: Baseline

Change From Baseline in Diastolic Blood Pressure at Week 12

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 12

Change From Baseline in Diastolic Blood Pressure at Week 2

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 2

Change From Baseline in Diastolic Blood Pressure at Week 4

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 4

Change From Baseline in Diastolic Blood Pressure at Week 8

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 8

Change From Baseline in Fasting Plasma Glucose at Week 12

The change from baseline is the Week 12 FPG minus the Week 0 fasting plasma glucose (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Baseline and Week 12

Change From Baseline in Fasting Plasma Glucose at Week 2

The change from baseline is the Week 2 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Baseline and Week 2

Change From Baseline in Fasting Plasma Glucose at Week 4

The change from baseline is the Week 4 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Baseline and Week 4

Change From Baseline in Fasting Plasma Glucose at Week 8

The change from baseline is the Week 8 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Baseline and Week 8

Change From Baseline in HbA1c at Week 12

HbA1c is measured as percent. The change from baseline is the Week 12 HbA1c percent minus the Week 0 HbA1c percent (last observation carried forward [LOCF]). (NCT01059825)
Timeframe: Baseline and Week 12

Change From Baseline in HbA1C at Week 2

HbA1c is measured as percent. The change from baseline is the Week 2 HbA1c percent minus the Week 0 HbA1c percent (LOCF). (NCT01059825)
Timeframe: Baseline and Week 2

Change From Baseline in HbA1c at Week 4

HbA1c is measured as percent. The change from baseline is the Week 4 HbA1c percent minus the Week 0 HbA1c percent (LOCF). (NCT01059825)
Timeframe: Baseline and Week 4

Change From Baseline in HbA1c at Week 8

HbA1c is measured as percent. The change from baseline is the Week 8 HbA1c percent minus the Week 0 HbA1c percent (LOCF). (NCT01059825)
Timeframe: Baseline and Week 8

Change From Baseline in Systolic Blood Pressure at Week 12

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 12

Change From Baseline in Systolic Blood Pressure at Week 2

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 2

Change From Baseline in Systolic Blood Pressure at Week 4

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 4

Change From Baseline in Systolic Blood Pressure at Week 8

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 8

Number of Participants Who Discontinued Study Medication Due to an AE

An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin and excludes a temporary discontinuation of study medication. (NCT01059825)
Timeframe: Up to 84 days

Number of Participants Who Experienced an Advere Event (AE)

An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin. (NCT01059825)
Timeframe: Up to 98 days

Percent Change From Baseline in Body Weight at Week 12

The percent change from baseline is the ([Week 12 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF). (NCT01059825)
Timeframe: Baseline and Week 12

Percent Change From Baseline in Body Weight at Week 2

The percent change from baseline is the ([Week 2 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF). (NCT01059825)
Timeframe: Baseline and Week 2

Percent Change From Baseline in Body Weight at Week 4

The percent change from baseline is the ([Week 4 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF). (NCT01059825)
Timeframe: Baseline and Week 4

Percent Change From Baseline in Body Weight at Week 8

The percent change from baseline is the ([Week 8 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF). (NCT01059825)
Timeframe: Baseline and Week 8

Percentage of Participants Achieving HbA1C <6.5% at Week 12

Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Week 12

Percentage of Participants Achieving HbA1c <7% at Week 12

Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Week 12

Trials

3 trials available for metformin and Genital Diseases, Female