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

University of Colorado Denver (CU Denver)

Status and phase

Completed

Phase 4

Conditions

Type 1 Diabetes

Treatments

Drug: Sugar Pill

Drug: Sitagliptin

Study type

Interventional

Funder types

Other

Identifiers

NCT00978796

Merck IISP-32888

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.