Metformin and Sitagliptin in Women With Previous Gestational Diabetes

NCT01336322 | Completed Phase 2 DMC

• 1 other identifier: SITA-previousGDM
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-diabetes

Keywords

beta-cell function; insulin resistance

Outcome Measures

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)

  4 months

Secondary Outcomes (2)

• Insulin resistance

  4 months

• Glucose control

  4 months

Study Arms (3)

Metformin

ACTIVE COMPARATOR

Metformin 850 mg bid

Drug: Metformin

Sitagliptin

ACTIVE COMPARATOR

Sitagliptin 100 mg qd

Drug: Sitagliptin

Sitagliptin+Metformin

ACTIVE COMPARATOR

Sitagliptin 100 mg qd plus Metformin 850 mg bid

Drug: Sitagliptin + Metformin

Interventions

Metformin DRUG

Metformin 850 mg bid

Also known as: Glucophage

Metformin

Sitagliptin DRUG

Sitagliptin 100 mg qd

Also known as: januvia

Sitagliptin

Sitagliptin + Metformin DRUG

sitagliptin 100mg + metformin 850mg

Also known as: janumet

Sitagliptin+Metformin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pisa: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Department of Endocrinology and Metabolism, University of Pisa

Pisa, 56124, Italy

Location

MeSH Terms

Conditions

Glucose Intolerance; Insulin Resistance

Interventions

Metformin; Sitagliptin Phosphate; Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Stefano Del Prato, MD

  University of Pisa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Resercher

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: April 15, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: March 25, 2019

Record last verified: 2019-03

Locations

IT (1)