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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00978796
• Other study ID #: Merck IISP-32888
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2009
• Last updated: March 29, 2010
• Start date: September 2009
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: University of Colorado Denver School of Medicine Barbara Davis Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Barbara Davis Center for Childhood Diabetes	Aurora	Colorado

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determine differences in fructosamine values		baseline, 4 and 8 weeks
Secondary	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