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CompletedNCT01336322Updated Mar 25, 2019

Metformin and Sitagliptin in Women With Previous Gestational Diabetes

A Phase 2 interventional study of Metformin and Sitagliptin in Pre-diabetes, sponsored by University of Pisa. Completed at 1 site in Italy. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-03-25.

Sponsored by University of Pisa · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Pre-diabetes

Keywords

  • beta-cell function
  • insulin resistance
03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's enrollment of 40 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

University of Pisa is the lead sponsor of 111 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Metformin

    Metformin 850 mg bid

    Drug: Metformin

  • Active comparator
    Sitagliptin

    Sitagliptin 100 mg qd

    Drug: Sitagliptin

  • Active comparator
    Sitagliptin+Metformin

    Sitagliptin 100 mg qd plus Metformin 850 mg bid

    Drug: Sitagliptin + Metformin

Interventions

  • DrugMetformin

    Metformin 850 mg bid

    Also known as: Glucophage

  • DrugSitagliptin

    Sitagliptin 100 mg qd

    Also known as: januvia

  • DrugSitagliptin + Metformin

    sitagliptin 100mg + metformin 850mg

    Also known as: janumet

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 4 months

Secondary outcomes

  1. Insulin resistance

    Sitagliptin and/or metformin effects on insulin resistance, evaluated by clamp, HOMA-index and ISI-Method..

    Time frame: 4 months

  2. Glucose control

    Sitagliptin and/or metformin effects on glucose control evaluated by OGTT and HbA1c levels.

    Time frame: 4 months

07

Study locations

1 site
  • Department of Endocrinology and Metabolism, University of Pisa
    Pisa, 56124, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01336322
Lead sponsor
University of Pisa
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Prof. Stefano Del Prato (Clinical Resercher, University of Pisa) — Principal investigator
First posted
Apr 15, 2011
Start date
May 2011
Primary completion
Dec 2017
Completion
Dec 2018
Last update
Mar 25, 2019

Study contacts

Stefano Del Prato, MD
principal investigator · University of Pisa

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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