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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01718093
First Posted: October 31, 2012
Last Update Posted: April 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Luisa M. Rodriguez, Baylor College of Medicine
  Purpose
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.

Condition Intervention Phase
Type 1 Diabetes Drug: Sitagliptin Drug: Metformin Drug: Sitagliptin + Metformin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Assess the Glucose Lowering Effect of Metformin and Sitagliptin in Adolescents With Type 1 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Luisa M. Rodriguez, Baylor College of Medicine:

Primary Outcome Measures:
  • 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. [ Time Frame: 10 - 15 weeks ]
    Glucose concentrations and AUC glucose calculation


Enrollment: 21
Actual Study Start Date: October 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Insulin plus sitagliptin
The subjects continued their usual insulin regimen throughout the study. Sitagliptin was started and continued at 50 mg orally twice daily
Drug: Sitagliptin
up to 50 mg twice a day
Other Name: Januvia
Active Comparator: 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.
Drug: Metformin
up to 1000 mg twice a day
Other Name: Glucophage
Active Comparator: 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.
Drug: Sitagliptin + Metformin
up to 50/1000 mg twice a day
Other Name: Sitagliptin + Metformin = Janumet

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718093


Locations
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Luisa M. Rodriguez, MD, MS Baylor College of Medicine
  More Information

Responsible Party: Luisa M. Rodriguez, Assistant Professor - Department of Pediatrics - Endocrinology and Metabolism, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01718093     History of Changes
Other Study ID Numbers: H-29924
DK096067 ( Other Identifier: NIH )
First Submitted: October 29, 2012
First Posted: October 31, 2012
Last Update Posted: April 24, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Luisa M. Rodriguez, Baylor College of Medicine:
Adolescents

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Metformin
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action