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CompletedNCT01718093Updated Apr 24, 2017

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

A Phase 4 interventional study of Sitagliptin and Metformin in Type 1 Diabetes, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2017-04-24.

Sponsored by Baylor College of Medicine · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
13 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Type 1 Diabetes

Keywords

  • Adolescents
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 21 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.

Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 18 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • DrugSitagliptin

    up to 50 mg twice a day

    Also known as: Januvia

  • DrugMetformin

    up to 1000 mg twice a day

    Also known as: Glucophage

  • DrugSitagliptin + Metformin

    up to 50/1000 mg twice a day

    Also known as: Sitagliptin + Metformin = Janumet

06

What researchers measure

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

    Time frame: 10 - 15 weeks

07

Study locations

1 site
  • Baylor College of Medicine
    Houston, Texas 77030, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01718093
Lead sponsor
Baylor College of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Luisa M. Rodriguez (Assistant Professor - Department of Pediatrics - Endocrinology and Metabolism, Baylor College of Medicine) — Principal investigator
First posted
Oct 31, 2012
Start date
Oct 2012
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Apr 24, 2017

Study contacts

Luisa M. Rodriguez, MD, MS
principal investigator · Baylor College of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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