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Metformin and Sitagliptin in Women With Previous Gestational Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Pisa.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
University of Pisa
ClinicalTrials.gov Identifier:
NCT01336322
First received: April 13, 2011
Last updated: April 19, 2011
Last verified: April 2011

April 13, 2011
April 19, 2011
May 2011
December 2012   (final data collection date for primary outcome measure)
Beta-cell function [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Sitagliptin and/or metformin effects on beta-cell function (ISR = Insulin Secretion Rate) evaluated by mathematical model by Mari A. (Am J Physiology 2002)
Same as current
Complete list of historical versions of study NCT01336322 on ClinicalTrials.gov Archive Site
  • Insulin resistance [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Sitagliptin and/or metformin effects on insulin resistance, evaluated by clamp, HOMA-index and ISI-Matsuda.
  • Glucose control [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Sitagliptin and/or metformin effects on glucose control evaluated by OGTT and HbA1c levels.
Same as current
Not Provided
Not Provided
 
Metformin and Sitagliptin in Women With Previous Gestational Diabetes
Effects of Treatment With Metformin and/or Sitagliptin on Beta-cell Function and Insulin Resistance in Women With Previous Gestational Diabetes

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pre-diabetes
  • Drug: Metformin
    Metformin 850 mg bid
  • Drug: Sitagliptin
    Sitagliptin 100 mg qd
  • Drug: Sitagliptin + Metfomin
    Sitagliptin 100 mg qd + Metformin 850 mg bid
  • Active Comparator: Metformin
    Metformin 850 mg bid
    Intervention: Drug: Metformin
  • Active Comparator: Sitagliptin
    Sitagliptin 100 mg qd
    Intervention: Drug: Sitagliptin
  • Active Comparator: Sitagliptin+Metformin
    Sitagliptin 100 mg qd + Metformin 850 mg bid
    Intervention: Drug: Sitagliptin + Metfomin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
45
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
No
Contact: Stefano Del Prato, MD +39 050 995103 stefano.delprato@med.unipi.it
Contact: Alessandra Bertolotto, MD
Italy
 
NCT01336322
SITA-previousGDM
Yes
Del Prato Stefano, MD, University of Pisa
University of Pisa
Merck Sharp & Dohme Corp.
Principal Investigator: Stefano Del Prato, MD University of Pisa
University of Pisa
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP