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

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

Sponsors

Lead Sponsor: University of Colorado Denver School of Medicine Barbara Davis Center

Source University of Colorado Denver School of Medicine Barbara Davis Center
Brief Summary

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.

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.

Overall Status Completed
Start Date September 2009
Completion Date March 2010
Primary Completion Date January 2010
Phase Phase 4
Study Type Interventional
Primary 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 Assessment done at week 4 and week 8
Secondary Outcome
Measure Time Frame
Determine differences in fructosamine values 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 Assessed at week 4 and week 8
Enrollment 20
Condition
Intervention

Intervention Type: Drug

Intervention Name: Sitagliptin

Description: Sitagliptin 100mg tablet taken orally once daily for 4 weeks and then switch over to sugar pill taken daily for 4 weeks

Arm Group Label: Sitagliptin

Other Name: Januvia

Intervention Type: Drug

Intervention Name: Sugar Pill

Description: Sugar pill taken daily for 4 weeks and then switched over to active comparator of sitagliptin 100mg tablet taken daily for 4 weeks

Arm Group Label: Sugar pill

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Official
Location
Facility: Barbara Davis Center for Childhood Diabetes
Location Countries

United States

Verification Date

March 2010

Responsible Party

Name Title: Satish K. Garg

Organization: Barbara Davis Center for Childhood Diabetes

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Sitagliptin

Type: Active Comparator

Description: Patients will receive sitagliptin for 4 weeks and then cross over to sugar pill

Label: Sugar pill

Type: Placebo Comparator

Description: Subjects will receive sugar pill for 4 weeks and then cross over to active sitagliptin

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov