Metformin and Sitagliptin in Women With Previous Gestational Diabetes

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified April 2011 by University of Pisa.
Recruitment status was: Not yet recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01336322

First Posted: April 15, 2011

Last Update Posted: April 20, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Merck Sharp & Dohme Corp.

Information provided by:

University of Pisa

Purpose

The goal of the present research is to compare the effects of treatment with metformin and sitagliptin, alone or in association, in women with previous gestational diabetes to evaluate the impact of the two drugs on beta-cell function. The study results may contribute to give a rational approach for future investigations.

Condition	Intervention	Phase
Pre-diabetes	Drug: Metformin Drug: Sitagliptin Drug: Sitagliptin + Metfomin	Phase 2


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Drug Information available for: Metformin Metformin hydrochloride Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Further study details as provided by University of Pisa:

Primary Outcome Measures:

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)

Secondary Outcome Measures:

Insulin resistance [ Time Frame: 4 months ]
Sitagliptin and/or metformin effects on insulin resistance, evaluated by clamp, HOMA-index and ISI-Matsuda.
Glucose control [ Time Frame: 4 months ]
Sitagliptin and/or metformin effects on glucose control evaluated by OGTT and HbA1c levels.


Estimated Enrollment:	45
Study Start Date:	May 2011
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Metformin Metformin 850 mg bid	Drug: Metformin Metformin 850 mg bid
Active Comparator: Sitagliptin Sitagliptin 100 mg qd	Drug: Sitagliptin Sitagliptin 100 mg qd
Active Comparator: Sitagliptin+Metformin Sitagliptin 100 mg qd + Metformin 850 mg bid	Drug: Sitagliptin + Metfomin Sitagliptin 100 mg qd + Metformin 850 mg bid

Detailed Description:

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female subjects aged ≥18 and ≤45 years
Caucasian race
History of previous gestational diabetes (in the screening) during pregnancy, defined according to Carpenter and Coustan criteria
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

Contacts and Locations

Information from the National Library of Medicine

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

Contacts


Contact: Stefano Del Prato, MD	+39 050 995103	stefano.delprato@med.unipi.it
Contact: Alessandra Bertolotto, MD

Locations


Italy
Department of Endocrinology and Metabolism, University of Pisa	Active, not recruiting
Pisa, Italy, 56124

Sponsors and Collaborators

University of Pisa

Merck Sharp & Dohme Corp.

Investigators


Principal Investigator:	Stefano Del Prato, MD	University of Pisa

More Information


Responsible Party:	Del Prato Stefano, MD, University of Pisa
ClinicalTrials.gov Identifier:	NCT01336322 History of Changes
Other Study ID Numbers:	SITA-previousGDM
First Submitted:	April 13, 2011
First Posted:	April 15, 2011
Last Update Posted:	April 20, 2011
Last Verified:	April 2011

Keywords provided by University of Pisa:


beta-cell function insulin resistance

Additional relevant MeSH terms:


Diabetes Mellitus Insulin Resistance Diabetes, Gestational Prediabetic State Glucose Intolerance Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Hyperinsulinism Pregnancy Complications Hyperglycemia	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

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