Overview

Effects of Sitagliptin (Januvia®) on Blood Glucose Control in Patients With Type 1 Diabetes

Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
0
Participant gender:
All
Summary
This is a multi-center, prospective, randomized, double-blind, parallel, placebo controlled clinical trial evaluating the efficacy of sitagliptin in suppressing glucagon release in subjects with type 1 diabetes over a 16 week treatment period. The hypothesis of this study is that sitagliptin (Januvia™) will decrease post-prandial glucagon release and may result in improved glucose control in adult patients with type 1 diabetes. There is only one small, pilot study of sitagliptin in patients with type 1 diabetes which significantly reduced total daily insulin dose and A1c values while improving mean blood glucose (MBG) and time spent in euglycemic range (1). In the pilot study, GLP-1 and glucagon levels were not assessed. The purpose of this trial is to determine if sitagliptin can suppress the paradoxical rise of glucagon, and thus can decrease A1c. This study will enroll a maximum of 140 patients (with an expected 10% dropout rate) with A1c values between 7.5-10% who will be randomized in a 1:1 fashion to either the study drug or placebo. 100 of these patients will wear a continuous glucose monitor. Subjects may be using insulin via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI). The clinic visits will be conducted at screening, -1 week, baseline/randomization, 4 weeks, 12 weeks, and 16 weeks in addition to telephone visits (Appendix 1 and 2). At home, starting at week 0 (randomization/baseline), subjects will take 100 mg/day of sitagliptin or placebo and continue for the study duration. Laboratory analysis will be performed at various time points assessing glucagon, A1c, C-peptide, glucagon-like-peptide-1 (GLP-1), glucose-dependent insulinotropic peptide (GIP), and insulin levels.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Colorado Denver School of Medicine Barbara Davis Center
Treatments:
Sitagliptin Phosphate
Criteria
Inclusion Criteria:

- Signed informed consent before any study-related activities

- Male or female aged 18 to 70 years

- Type 1 diabetes mellitus duration > 1 year

- Treatment with MDI or CSII therapy for at least 3 months prior to screening visit;
stable insulin dose for the last 1 month

- No use of pramlintide, saxagliptin, metformin or sitagliptin for 1 month prior to
enrollment

- A1c 7.5-10%

- Willingness to routinely practice at least 2-4 blood glucose measurements per day

- BMI ≤ 35 kg/m2

- Ability and willingness to adhere to the protocol including daily oral dose of study
drug or placebo and week-long CGM wear

- Willing to complete phone and clinic visits

- Ability to speak, read and write English

Exclusion Criteria:

- Use of oral, inhaled or pre-mixed insulin

- Pregnant or intention to become pregnant during the course of the study not using
adequate birth control methods

- Severe unexplained hypoglycemia requiring emergency treatment in the previous 3 months

- Use of systemic or inhaled corticosteroids

- History of hemoglobinopathies

- Diagnosis of anemia

- Post-renal transplantation, currently undergoing dialysis, creatinine >2.0 mg/dl or a
calculated creatinine clearance of <50 mL/min

- Advanced retinopathy needing laser procedure or vitrectomy

- History of pancreatitis

- Extensive skin changes/diseases that inhibit wearing a sensor on normal skin

- Known allergy to adhesives

- Known allergy to study medication

- Participation in another investigational study protocol within 30 days prior to
enrollment

- Any other condition, as determined by the investigator, which could make the subject
unsuitable for the trial, impairs the subject's suitability for the trial, or impairs
the validity of the informed consent