Metformin and Sitagliptin in Women With Previous Gestational Diabetes
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ClinicalTrials.gov Identifier: NCT01336322 |
Recruitment Status :
Completed
First Posted : April 15, 2011
Last Update Posted : March 25, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pre-diabetes | Drug: Metformin Drug: Sitagliptin Drug: Sitagliptin + Metformin | Phase 2 |
A randomized, double blinded study, on 45 women with previous gestational diabetes and impaired glucose tolerance (IGT) or impaired fasting glucose (IFG) to assess the effects of a 4-month treatment with metformin and/or a dipeptidyl peptidase-4 inhibitor (sitagliptin) on beta-cell function and insulin resistance.
At baseline, all women will have a standardized medical history, physical, and laboratory examination. Plasma glucose, insulin, pro-insulin, C-peptide, glucagon, adipokines, pro-inflammatory molecules, and lipid profile will be determined in fasting condition. A 75g OGTT will be performed after an overnight fasting and sample will be drawn at 15, 30, 60, 90 and 120 minutes for plasma glucose, C-peptide, glucagon and GLP-1 determinations. Women with IFG or IGT will be recruited and undergo to a hyperglycemic clamp with arginin bolus at the end of the test. Then the women will be randomized in 3 treatment groups: metformin (850 mg bid), sitagliptin (100 mg qd)or metformin (850 mg bid) + sitagliptin (100 mg qd). After 4-month treatment, the baseline evaluation will be repeated.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Effects of Treatment With Metformin and/or Sitagliptin on Beta-cell Function and Insulin Resistance in Women With Previous Gestational Diabetes |
Study Start Date : | May 2011 |
Actual Primary Completion Date : | December 2017 |
Actual Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Metformin
Metformin 850 mg bid
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Drug: Metformin
Metformin 850 mg bid
Other Name: Glucophage |
Active Comparator: Sitagliptin
Sitagliptin 100 mg qd
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Drug: Sitagliptin
Sitagliptin 100 mg qd
Other Name: januvia |
Active Comparator: Sitagliptin+Metformin
Sitagliptin 100 mg qd plus Metformin 850 mg bid
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Drug: Sitagliptin + Metformin
sitagliptin 100mg + metformin 850mg
Other Name: janumet |
- Beta-cell function [ Time Frame: 4 months ]Sitagliptin and/or metformin effects on beta-cell function (ISR = Insulin Secretion Rate) evaluated by mathematical model by Mari A. (Am J Physiology 2002)
- Insulin resistance [ Time Frame: 4 months ]Sitagliptin and/or metformin effects on insulin resistance, evaluated by clamp, HOMA-index and ISI-Method..
- Glucose control [ Time Frame: 4 months ]Sitagliptin and/or metformin effects on glucose control evaluated by OGTT and HbA1c levels.

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Female subjects aged ≥18 and ≤45 years
- Caucasian race
- History of previous gestational diabetes (in the screening) during pregnancy.
- Female of childbearing potential must use effective contraceptive measures for at last 1 month prior to entry into the study and should continue to use the some contraceptive method during the overall study period
- Written informed consent obtained
Exclusion Criteria:
- Patients diagnosed with type 1 insulin dependent diabetes
- Diagnosis of diabetes in the 75g OGTT performed at entry
- BMI ≤18 or ≥50 Kg/m2
- Chronic impaired renal function
- Impaired liver function as shown by transaminase levels ≥ twice above the upper normal range
- History of hypersensitivity to metformin
- Pregnant or breast-feeding women, or women planning to become pregnant during the study
- Failure to use adequate contraception (Women of current reproductive only)
- Mental condition rending the subject unable to understand the nature, scope and possible consequences of the study
- Any clinically significant major organ system disease
- Patients with underlying concomitant medication requiring a long-term use of drugs potentially acting on glucose metabolism (e.g. corticosteroids, diuretics, beta-adrenergic drugs or others)
- Treatment or likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
- History of drug or alcohol abuse within the last 2 years or current addiction to substances of abuse
- Any disease or condition that in the opinion of the investigator may interfere with the completion of the study
- Subjects unlikely to comply with the protocol

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01336322
Italy | |
Department of Endocrinology and Metabolism, University of Pisa | |
Pisa, Italy, 56124 |
Principal Investigator: | Stefano Del Prato, MD | University of Pisa |
Responsible Party: | Prof. Stefano Del Prato, Clinical Resercher, University of Pisa |
ClinicalTrials.gov Identifier: | NCT01336322 |
Other Study ID Numbers: |
SITA-previousGDM |
First Posted: | April 15, 2011 Key Record Dates |
Last Update Posted: | March 25, 2019 |
Last Verified: | March 2019 |
beta-cell function insulin resistance |
Diabetes, Gestational Diabetes Mellitus Prediabetic State Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Pregnancy Complications Metformin Sitagliptin Phosphate |
Hypoglycemic Agents Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |