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Trial record 18 of 2472 for:    Diabetes | "Diabetes Mellitus, Insulin-Dependent"

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

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ClinicalTrials.gov Identifier: NCT01227460
Recruitment Status : Completed
First Posted : October 25, 2010
Last Update Posted : May 21, 2014
Sponsor:
Information provided by (Responsible Party):
Satish K. Garg, University of Colorado Denver School of Medicine Barbara Davis Center

Tracking Information
First Submitted Date  ICMJE October 22, 2010
First Posted Date  ICMJE October 25, 2010
Last Update Posted Date May 21, 2014
Study Start Date  ICMJE November 2010
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2010)
To demonstrate a decrease in post-prandial glucagon release as assessed by glucagon area under the curve (AUC) for 3 hours during 4 hour meal tolerance tests [ Time Frame: Primary outcome meausre will be recoreded after 16 weeks of treatment ]
To demonstrate a decrease in post-prandial glucagon release as assessed by glucagon area under the curve (AUC) for 3 hours during 4 hour meal tolerance tests
Original Primary Outcome Measures  ICMJE
 (submitted: October 22, 2010)
To demonstrate a decrease in post-prandial glucagon release as assessed by glucagon area under the curve (AUC) for 3 hours during 4 hour meal tolerance tests [ Time Frame: The primary endpoint is a reduction glucagon AUC after 16 weeks of treatment ]
To demonstrate a decrease in post-prandial glucagon release as assessed by glucagon area under the curve (AUC) for 3 hours during 4 hour meal tolerance tests
Change History Complete list of historical versions of study NCT01227460 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2010)
Secondary objectives: 1. To demonstrate a 0.3% decrease in A1c in patients with type 1 diabetes after 16 weeks of treatment with sitagliptin. 2. To evaluate changes in total, basal and bolus insulin dose while on sitagliptin. [ Time Frame: Secondary outcome meausre will be recoreded after 16 weeks of treatment ]
Secondary objectives:
  1. To demonstrate a 0.3% decrease in A1c in patients with type 1 diabetes after 16 weeks of treatment with sitagliptin.
  2. To evaluate changes in total, basal and bolus insulin dose while on sitagliptin.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2010)
Secondary objectives: 1. To demonstrate a 0.3% decrease in A1c in patients with type 1 diabetes after 16 weeks of treatment with sitagliptin. 2. To evaluate changes in total, basal and bolus insulin dose while on sitagliptin. [ Time Frame: : reduction of A1c by 0.3%, time spent in hypo- and hyperglycemic ranges, and changes in total, basal, and bolus insulin doses after 16 weeks ]
Secondary objectives:
  1. To demonstrate a 0.3% decrease in A1c in patients with type 1 diabetes after 16 weeks of treatment with sitagliptin.
  2. To evaluate changes in total, basal and bolus insulin dose while on sitagliptin.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Sitagliptin (Januvia®) on Blood Glucose Control in Patients With Type 1 Diabetes
Official Title  ICMJE Effects of Sitagliptin (Januvia®) on Blood Glucose Control in Patients With Type 1 Diabetes and CGM Substudy of the Investigator Initiated Study Protocol Effects of Sitagliptin (Januvia) on Glucagon Suppression and GLP-1 Levels in Patients With Type 1 Diabetes; CGM Substudy
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE
  • Drug: Sitagliptin
    pill/tablet form of 100mg each. will take one tablet a day throughout study
  • Drug: Sugar Pill
    100mg tablet once a day
Study Arms  ICMJE
  • Experimental: Sitagliptin
    Intervention: Drug: Sitagliptin
  • Placebo Comparator: Sugar Pill
    Intervention: Drug: Sugar Pill
Publications * Garg SK, Moser EG, Bode BW, Klaff LJ, Hiatt WR, Beatson C, Snell-Bergeon JK. Effect of sitagliptin on post-prandial glucagon and GLP-1 levels in patients with type 1 diabetes: investigator-initiated, double-blind, randomized, placebo-controlled trial. Endocr Pract. 2013 Jan-Feb;19(1):19-28. doi: 10.4158/EP12100.OR.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 22, 2010)
140
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01227460
Other Study ID Numbers  ICMJE MRK-SI-100
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Satish K. Garg, University of Colorado Denver School of Medicine Barbara Davis Center
Study Sponsor  ICMJE University of Colorado Denver School of Medicine Barbara Davis Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Satish K Garg, MD University of Colorado Denver, Barbara Davis Center
PRS Account University of Colorado Denver School of Medicine Barbara Davis Center
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP