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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Baylor College of Medicine.
Recruitment status was:  Recruiting
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Luisa M. Rodriguez, Baylor College of Medicine Identifier:
First received: October 29, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
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: 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 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 ]

Estimated Enrollment: 48
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Insulin plus sitagliptin Drug: Sitagliptin
up to 50 mg twice a day
Other Name: Januvia
Active Comparator: Insulin plus metformin Drug: Metformin
up to 1000 mg twice a day
Other Name: Glucophage
Active Comparator: Insulin plus sitagliptin and metformin 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.

Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01718093

Contact: Kathy Shippy, RN, CCRP 832-824-1268

United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Kathy Shippy, RN, CCRP    832-824-1268   
Principal Investigator: Luisa Rodriguez, MD, MS         
Sub-Investigator: Katherine Velez, MD         
Sub-Investigator: Bonnie Goldsmith, MD         
Sub-Investigator: Morey W. Haymond, MD         
Sub-Investigator: Maria J. Redondo, MD, PhD, MPH         
Sub-Investigator: Shannon French, MD         
Sponsors and Collaborators
Baylor College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 Identifier: NCT01718093     History of Changes
Other Study ID Numbers: H-29924  DK096067 
Study First Received: October 29, 2012
Last Updated: October 29, 2012

Keywords provided by Baylor College of Medicine:

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on February 24, 2017