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Metformin and Sitagliptin in Women With Previous Gestational Diabetes

Primary Purpose

Pre-diabetes

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Metformin
Sitagliptin
Sitagliptin + Metformin
Sponsored by
University of Pisa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre-diabetes focused on measuring beta-cell function, insulin resistance

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Endocrinology and Metabolism, University of Pisa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Metformin

Sitagliptin

Sitagliptin+Metformin

Arm Description

Metformin 850 mg bid

Sitagliptin 100 mg qd

Sitagliptin 100 mg qd plus Metformin 850 mg bid

Outcomes

Primary Outcome Measures

Beta-cell function
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
Sitagliptin and/or metformin effects on insulin resistance, evaluated by clamp, HOMA-index and ISI-Method..
Glucose control
Sitagliptin and/or metformin effects on glucose control evaluated by OGTT and HbA1c levels.

Full Information

First Posted
April 13, 2011
Last Updated
March 21, 2019
Sponsor
University of Pisa
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01336322
Brief Title
Metformin and Sitagliptin in Women With Previous Gestational Diabetes
Official Title
Effects of Treatment With Metformin and/or Sitagliptin on Beta-cell Function and Insulin Resistance in Women With Previous Gestational Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pisa
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes
Keywords
beta-cell function, insulin resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Del Prato, MD
Organizational Affiliation
University of Pisa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Endocrinology and Metabolism, University of Pisa
City
Pisa
ZIP/Postal Code
56124
Country
Italy

12. IPD Sharing Statement

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Metformin and Sitagliptin in Women With Previous Gestational Diabetes

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