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Completed

NCT Number: NCT00978796

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sitagliptin

Drug

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

Other names: Januvia

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

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

    Time frame: Assessment done at week 4 and week 8

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 17, 2009
Registry last updated
Mar 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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