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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:


Further study details as provided by University of Pisa:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.


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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Del Prato Stefano, MD, University of Pisa
ClinicalTrials.gov Identifier: NCT01336322     History of Changes
Other Study ID Numbers: SITA-previousGDM
Study First Received: April 13, 2011
Last Updated: April 19, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by University of Pisa:
beta-cell function
insulin resistance

Additional relevant MeSH terms:
Diabetes Mellitus
Insulin Resistance
Diabetes, Gestational
Glucose Intolerance
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Pregnancy Complications
Hyperglycemia
Sitagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014