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

Overview[ - collapse ][ - ]

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.
ConditionType 1 Diabetes
InterventionDrug: Sitagliptin
Drug: Metformin
Drug: Sitagliptin + Metformin
PhasePhase 4
SponsorBaylor College of Medicine
Responsible PartyBaylor College of Medicine
ClinicalTrials.gov IdentifierNCT01718093
First ReceivedOctober 29, 2012
Last UpdatedOctober 29, 2012
Last verifiedMay 2012

Tracking Information[ + expand ][ + ]

First Received DateOctober 29, 2012
Last Updated DateOctober 29, 2012
Start DateOctober 2012
Estimated Primary Completion DateDecember 2015
Current Primary Outcome MeasuresTo 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] [Designated as safety issue: No]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleA Pilot Study to Assess the Glucose Lowering Effect of Metformin and Sitagliptin in Adolescents With Type 1 Diabetes
Official TitleA Pilot Study to Assess the Glucose Lowering Effect of Metformin and Sitagliptin in Adolescents With Type 1 Diabetes Mellitus
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.
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionType 1 Diabetes
InterventionDrug: Sitagliptin
up to 50 mg twice a day
Other Names:
JanuviaDrug: Metformin
up to 1000 mg twice a day
Other Names:
GlucophageDrug: Sitagliptin + Metformin
up to 50/1000 mg twice a day
Other Names:
Sitagliptin + Metformin = Janumet
Study Arm (s)
  • Active Comparator: Insulin plus sitagliptin
  • Active Comparator: Insulin plus metformin
  • Active Comparator: Insulin plus sitagliptin and metformin

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment48
Estimated Completion DateDecember 2015
Estimated Primary Completion DateDecember 2015
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
GenderBoth
Ages13 Years
Accepts Healthy VolunteersNo
ContactsContact: Kathy Shippy, RN, CCRP
832-824-1268
klshippy@texaschildrens.org
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT01718093
Other Study ID NumbersH-29924
Has Data Monitoring CommitteeYes
Information Provided ByBaylor College of Medicine
Study SponsorBaylor College of Medicine
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators Principal Investigator: Luisa M. Rodriguez, MD, MS Baylor College of Medicine
Verification DateMay 2012

Locations[ + expand ][ + ]

Baylor College of Medicine
Houston, Texas, United States, 77030
Contact: Kathy Shippy, RN, CCRP | 832-824-1268 | klshippy@texaschildrens.org
Principal Investigator: Luisa Rodriguez, MD, MS
Recruiting