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

NCT00978796 | Completed Phase 4

• 1 other identifier: Merck IISP-32888
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

Diabetes Mellitus; Type 1 diabetes; glucose variability

Outcome Measures

Primary Outcomes (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

  Assessment done at week 4 and week 8

Secondary Outcomes (2)

• Determine differences in fructosamine values

  baseline, 4 and 8 weeks

• 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

Study Arms (2)

Sitagliptin

ACTIVE COMPARATOR

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

Drug: Sitagliptin

Sugar pill

PLACEBO COMPARATOR

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

Drug: Sugar Pill

Interventions

Sitagliptin DRUG

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

Also known as: Januvia

Sitagliptin

Sugar Pill DRUG

Sugar pill taken daily for 4 weeks and then switched over to active comparator of sitagliptin 100mg tablet taken daily for 4 weeks

Sugar pill

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80010, United States

Location

Related Publications (2)

• 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.

  PMID: 23186950 DERIVED

• 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.

  PMID: 21923696 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Interventions

Sitagliptin Phosphate; Sugars

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Carbohydrates

Study Officials

• Satish Garg, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Samuel L Ellis, Pharm.D.

  University of Colorado School of Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2009
• First Posted: September 17, 2009
• Study Start: September 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 30, 2010

Record last verified: 2010-03

Locations

US (1)