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

This study has been completed.
Sponsor:
Information provided by:
University of Colorado Denver School of Medicine Barbara Davis Center
ClinicalTrials.gov Identifier:
NCT00978796
First received: September 14, 2009
Last updated: March 29, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Drug: Sitagliptin
Drug: Sugar Pill
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study Assessing Glucose Effects of Sitagliptin (Januvia) in Adult Patients With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Colorado Denver School of Medicine Barbara Davis Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine differences in fructosamine values [ Time Frame: baseline, 4 and 8 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: September 2009
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00978796

Locations
United States, Colorado
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80010
Sponsors and Collaborators
University of Colorado Denver School of Medicine Barbara Davis Center
Investigators
Principal Investigator: Satish Garg, MD University of Colorado, Denver
Principal Investigator: Samuel L Ellis, Pharm.D. University of Colorado School of Pharmacy
  More Information

No publications provided by University of Colorado Denver School of Medicine Barbara Davis Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Satish K. Garg, Barbara Davis Center for Childhood Diabetes
ClinicalTrials.gov Identifier: NCT00978796     History of Changes
Other Study ID Numbers: Merck IISP-32888
Study First Received: September 14, 2009
Last Updated: March 29, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Colorado Denver School of Medicine Barbara Davis Center:
Diabetes Mellitus
Type 1 diabetes
glucose variability

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014