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

NCT01718093 | Completed Phase 4 DMC

• 2 other identifiers: H-29924DK096067
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

Adolescents

Outcome Measures

Primary Outcomes (1)

• To determine the glucose lowering effect of metformin and sitagliptin alone and as combination therapy when used as adjuncts to insulin in adolescents with T1DM.

  Glucose concentrations and AUC glucose calculation

  10 - 15 weeks

Study Arms (3)

Insulin plus sitagliptin

ACTIVE COMPARATOR

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

Drug: Sitagliptin

Insulin plus metformin

ACTIVE COMPARATOR

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.

Drug: Metformin

Insulin plus sitagliptin and metformin

ACTIVE COMPARATOR

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.

Drug: Sitagliptin + Metformin

Interventions

Sitagliptin DRUG

up to 50 mg twice a day

Also known as: Januvia

Insulin plus sitagliptin

Metformin DRUG

up to 1000 mg twice a day

Also known as: Glucophage

Insulin plus metformin

Sitagliptin + Metformin DRUG

up to 50/1000 mg twice a day

Also known as: Sitagliptin + Metformin = Janumet

Insulin plus sitagliptin and metformin

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Sitagliptin Phosphate; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Luisa M. Rodriguez, MD, MS

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Department of Pediatrics - Endocrinology and Metabolism

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: October 31, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 24, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)