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Trial record 42 of 2791 for:    Type 1 Diabetes

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00978796
Recruitment Status : Completed
First Posted : September 17, 2009
Last Update Posted : March 30, 2010
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Sitagliptin Drug: Sugar Pill Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study Assessing Glucose Effects of Sitagliptin (Januvia) in Adult Patients With Type 1 Diabetes
Study Start Date : September 2009
Primary Completion Date : January 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Determine differences in fructosamine values [ Time Frame: baseline, 4 and 8 weeks ]
  2. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978796

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
Principal Investigator: Satish Garg, MD University of Colorado, Denver
Principal Investigator: Samuel L Ellis, Pharm.D. University of Colorado School of Pharmacy
More Information

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
First Posted: September 17, 2009    Key Record Dates
Last Update Posted: March 30, 2010
Last Verified: March 2010

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 Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action