A Pilot Study to Assess the Glucose Lowering Effect of Metformin and Sitagliptin in Adolescents With Type 1 Diabetes

NCT ID: NCT01718093

Last Updated: 2017-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2015-12-31

Brief Summary

The purpose of this study is to see if the use of metformin and sitagliptin used in conjunction with insulin can improve the blood sugars of teenagers with Type 1 diabetes.

Detailed Description

• The study will include a total of 4 visits. The time period between the very first visit and the very last visit will be between 10 and 15 weeks. Each participant will be randomized to one of the 3 groups in the study. The groups are as follows:
• Group 1: Insulin and sitagliptin
• Group 2: Insulin and metformin
• Group 3: Insulin and combination of sitagliptin and metformin
• The study is a randomized open label design. All subjects will undergo a screening visit; if inclusion and exclusion criteria are fulfilled they will be enrolled in the study. At the time of enrollment the subject will continue their home insulin regimen and will be randomized to an add an oral hypoglycemic agent(s) : metformin, sitagliptin or combination therapy (metformin and sitagliptin). The total duration on study medication will be 6 weeks. All subjects will undergo a baseline mixed meal tolerance test (MMTT) in their standard or usual insulin Each subject will undergo a total of two studies. Blood draws will be necessary.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin plus sitagliptin

The subjects continued their usual insulin regimen throughout the study. Sitagliptin was started and continued at 50 mg orally twice daily

Group Type: ACTIVE_COMPARATOR

Sitagliptin

Intervention Type: DRUG

up to 50 mg twice a day

Insulin plus metformin

The subjects continued their usual insulin regimen throughout the study. Metformin was started at 500 mg orally daily. The dose was increased over a 2 week period up to 2,000 mg per day as tolerated.

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

up to 1000 mg twice a day

Insulin plus sitagliptin and metformin

The subjects continued their usual insulin regimen throughout the study. Sitagliptin was started and continued at 50 mg orally twice daily. Metformin was started at 500 mg orally daily. The dose was increased over a 2 week period up to 2,000 mg per day as tolerated.

Group Type: ACTIVE_COMPARATOR

Sitagliptin + Metformin

Intervention Type: DRUG

up to 50/1000 mg twice a day

Interventions

Sitagliptin

up to 50 mg twice a day

Intervention Type: DRUG

Metformin

up to 1000 mg twice a day

Intervention Type: DRUG

Sitagliptin + Metformin

up to 50/1000 mg twice a day

Intervention Type: DRUG

Other Intervention Names

Januvia; Glucophage; Sitagliptin + Metformin = Janumet

Eligibility Criteria

Inclusion Criteria

• Age of 13 to 18 years
• HbA1c >7.5% but <10%
• Subjects must be on intensive insulin management
• Tanner stage greater than or equal to 4
• Must have T1DM for at least one year , T1DM defined by ADA criteria and having at least one of the following antibodies: Anti-GAD, Anti-islet, Anti-insulin
• C-peptide > 0.6 ng/ml

Exclusion Criteria

• Type 2 diabetes
• History of any other chronic condition (except hypothyroidism stable on medications)
• Actively taking medications that may affect glucose excursions (steroids or oral contraceptives)
• Evidence of anemia, clinically significant elevation of the liver enzymes (3 X normal), amylase or lipase (2 X normal), abnormal triclycerides (3 X normal), abnormal renal function test
• An unsupportive family environment and pregnant or lactating females

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Luisa M. Rodriguez

Assistant Professor - Department of Pediatrics - Endocrinology and Metabolism

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luisa M. Rodriguez, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

Other Identifiers

DK096067

Identifier Type: OTHER

Identifier Source: secondary_id

H-29924

Identifier Type: -

Identifier Source: org_study_id