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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sitagliptin
Sugar Pill
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Diabetes Mellitus, Type 1 diabetes, glucose variability

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Barbara Davis Center for Childhood Diabetes

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sitagliptin

Sugar pill

Arm Description

Patients will receive sitagliptin for 4 weeks and then cross over to sugar pill

Subjects will receive sugar pill for 4 weeks and then cross over to active sitagliptin

Outcomes

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

Secondary Outcome Measures

Determine differences in fructosamine values
Time spent in hypoglycemic and hyperglycemic excursions recorded on the DexCom STS continuous glucose monitor (CGM) at 3 time periods throughout the study

Full Information

First Posted
September 14, 2009
Last Updated
March 29, 2010
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT00978796
Brief Title
Assessing Glucose Effects of Sitagliptin (Januvia) in Adult Patients With Type 1 Diabetes
Official Title
Pilot Study Assessing Glucose Effects of Sitagliptin (Januvia) in Adult Patients With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Diabetes Mellitus, Type 1 diabetes, glucose variability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sitagliptin
Arm Type
Active Comparator
Arm Description
Patients will receive sitagliptin for 4 weeks and then cross over to sugar pill
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Subjects will receive sugar pill for 4 weeks and then cross over to active sitagliptin
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Other Intervention Name(s)
Januvia
Intervention Description
Sitagliptin 100mg tablet taken orally once daily for 4 weeks and then switch over to sugar pill taken daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Sugar Pill
Intervention Description
Sugar pill taken daily for 4 weeks and then switched over to active comparator of sitagliptin 100mg tablet taken daily for 4 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Determine differences in fructosamine values
Time Frame
baseline, 4 and 8 weeks
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satish Garg, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samuel L Ellis, Pharm.D.
Organizational Affiliation
University of Colorado School of Pharmacy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barbara Davis Center for Childhood Diabetes
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21923696
Citation
Ellis SL, Moser EG, Snell-Bergeon JK, Rodionova AS, Hazenfield RM, Garg SK. Effect of sitagliptin on glucose control in adult patients with Type 1 diabetes: a pilot, double-blind, randomized, crossover trial. Diabet Med. 2011 Oct;28(10):1176-81. doi: 10.1111/j.1464-5491.2011.03331.x.
Results Reference
derived
PubMed Identifier
23186950
Citation
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.
Results Reference
derived

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

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