Assessing Glucose Effects of Sitagliptin (Januvia) in Adult Patients With Type 1 Diabetes

March 29, 2010 updated by: University of Colorado, Denver

Pilot Study Assessing Glucose Effects of Sitagliptin (Januvia) in Adult Patients With Type 1 Diabetes

The purpose of this study is to determine the effects of sitagliptin on glucose variability both after meals and overnight in adult patients with type 1 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Improved post prandial glucose control with multiple daily injections of insulin in the DCCT study demonstrated significant reductions in microvascular complication. Similar to type 2 diabetes, patients with type 1 diabetes have a paradoxical increase in glucagon after meals which contribute to worsening post prandial glucose control. This proposed study is designed to determine if altering the glucagon axis by giving sitagliptin can improve glucose control in patients with type 1 diabetes.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80010
        • Barbara Davis Center for Childhood Diabetes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female adult, aged 18 to 70 years
  • Type 1 diabetes mellitus as established by medical history
  • Current treatment with MDI or CSII therapy for at least 3 months prior to screening visit; and using the same insulin during the last 1 month
  • HbA1c ≥ 8.5%
  • Subjects should routinely practice at least 2-4 blood glucose measurements per day
  • BMI ≤ 35 kg/m2
  • Subject must be able and willing to perform self-blood glucose monitoring and accept wearing a continuous glucose monitor for the total duration of the study
  • Willing to complete a routine medical visits every 3 months
  • Willing to complete a total of 7 phone visits
  • Able to speak, read, and write English

Exclusion Criteria:

  • On oral, inhaled or pre-mixed insulin
  • On Symlin
  • BMI > 35 kg/m2
  • Pregnant or intends to become pregnant during the course of the study
  • Severe unexplained hypoglycemia that required emergency treatment over the past 3 months
  • History of hemoglobinopathies
  • Diagnosis of anemia
  • HbA1C greater than 12%
  • Post-renal transplantation, currently undergoing dialysis, creatinine of >1.5mg/dl or a calculated creatinine clearance of <50 mL/min.
  • Have extensive skin changes/diseases that inhibit wearing the sensor on normal skin
  • Subjects who have a medical known allergy to adhesives
  • Subjects who have an allergy to medication being used
  • Currently participation in another investigational study protocol. Must have completed a previous study at least 30 days prior to being enrolled in this one
  • Have any condition that, in the opinion of the Investigator, would interfere with their participation in the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sitagliptin
Patients will receive sitagliptin for 4 weeks and then cross over to sugar pill
Drug: Sitagliptin
Sitagliptin 100mg tablet taken orally once daily for 4 weeks and then switch over to sugar pill taken daily for 4 weeks
Other Names:
  • Januvia
Placebo Comparator: Sugar pill
Subjects will receive sugar pill for 4 weeks and then cross over to active sitagliptin
Drug: Sugar Pill
Sugar pill taken daily for 4 weeks and then switched over to active comparator of sitagliptin 100mg tablet taken daily for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary objective of this pilot study is to compare 24-hour blood glucose values (overnight and pre- and post- prandial glucoses) in adult subjects with type 1 diabetes receiving either sitagliptin or placebo
Time Frame: Assessment done at week 4 and week 8
Assessment done at week 4 and week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine differences in fructosamine values
Time Frame: baseline, 4 and 8 weeks
baseline, 4 and 8 weeks
Time spent in hypoglycemic and hyperglycemic excursions recorded on the DexCom STS continuous glucose monitor (CGM) at 3 time periods throughout the study
Time Frame: Assessed at week 4 and week 8
Assessed at week 4 and week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

September 14, 2009

First Submitted That Met QC Criteria

September 16, 2009

First Posted (Estimate)

September 17, 2009

Study Record Updates

Last Update Posted (Estimate)

March 30, 2010

Last Update Submitted That Met QC Criteria

March 29, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Merck IISP-32888

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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