Type 1 DiabetesPhase 4NCT00978796
Assessing Glucose Effects of Sitagliptin (Januvia) in Adult Patients With Type 1 Diabetes
A Phase 4 study testing Sitagliptin and Sugar Pill in people with Type 1 Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Sitagliptin and Sugar Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Mar 2010
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80010
About this study
Official title: Pilot Study 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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Sitagliptin, Sugar Pill
- Keywords
- Diabetes Mellitus, Type 1 diabetes, glucose variability
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Also called Januvia
Sitagliptin 100mg tablet taken orally once daily for 4 weeks and then switch over to sugar pill taken daily for 4 weeks
Sugar PillDrug
Sugar pill taken daily for 4 weeks and then switched over to active comparator of sitagliptin 100mg tablet taken daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin | Active comparator | Patients will receive sitagliptin for 4 weeks and then cross over to sugar pill Receives: Drug: Sitagliptin |
| Sugar pill | Placebo comparator | Subjects will receive sugar pill for 4 weeks and then cross over to active sitagliptin Receives: Drug: Sugar Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Assessment done at week 4 and week 8
Secondary outcomes (2)
Determine differences in fructosamine values
Measured: 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
Measured: Assessed at week 4 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Investigators
- Satish Garg, MD, Principal investigator, University of Colorado, DenverSamuel L Ellis, Pharm.D., Principal investigator, University of Colorado School of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978796
- Sponsor's protocol ID
- Merck IISP-32888
- Status last verified
- Mar 2010
- First submitted
- 14 Sep 2009
- Last updated
- 30 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23186950Ellis 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.
PubMed 21923696