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DPP-4 Inhibition, Incretins and Islet Function (CODI24)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02089438
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
Bo Ahren, Lund University

Tracking Information
First Submitted Date  ICMJE March 14, 2014
First Posted Date  ICMJE March 17, 2014
Last Update Posted Date August 23, 2017
Study Start Date  ICMJE May 2014
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2014)
Postprandial glucose [ Time Frame: 180 min ]
The area under the 180 min curves for plasma glucose after each meal
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2014)
  • Postprandial insulin and glucagon [ Time Frame: 180 min ]
    The area under the 180 min curves for plasma insulin and glucagon after each meal
  • Postprandial glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) [ Time Frame: 180 min ]
    The area under the 180 min curves for plasma GLP-1 and GIP after each meal
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DPP-4 Inhibition, Incretins and Islet Function
Official Title  ICMJE Comparison of Three DPP-4 Inhibitors on 24 Hour Blood Glucose, Incretin Hormones and Islet Function in Patients With Type 2 Diabetes
Brief Summary Hypothesis is that DPP-4 inhibition affects glucose levels through changes in incretin and islet hormones. The study examines this in relation to breakfast, lunch and dinner over an entire 24h study period by the use of three different DPP-4 inhibitors and placebo.
Detailed Description The study is a single-center study with a cross-over design to examine glycemia, incretin hormones and islet hormones over a 24h study period with standardized breakfast, lunch and dinner after administration of placebo, saxagliptin, vildagliptin or sitagliptin.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Drug: Saxagliptin
    Saxagliptin (5 mg) is given before breakfast
    Other Name: Onglyza
  • Drug: Vildagliptin
    Vildagliptin (50mg) is given before breakfast and dinner
    Other Name: Galvus
  • Drug: Sitagliptin
    Sitagliptin (100 mg) is given before breakfast
    Other Name: Januvia
Study Arms  ICMJE
  • Experimental: Saxagliptin
    Ssaxagliptin is given before breakfast
    Intervention: Drug: Saxagliptin
  • Experimental: ´Sitagliptin
    Sitagliptin is given before breakfast
    Intervention: Drug: Sitagliptin
  • Experimental: Vildagliptin
    Vildagliptin is given before breakfast
    Intervention: Drug: Vildagliptin
Publications * Not Provided

*   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: March 14, 2014)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • • Caucasian men or women with type 2 diabetes diagnosed according to ICD10 at time of inclusion

    • Ongoing treatment with life style adjustment including diet and exercise regimen together with metformin as oral antidiabetic . Metformin therapy should be stable the last three months
    • Age 40-75 years
    • HbA1c 52-80 mmol/mol (inclusive)
    • BMI: 20-40 kg/m2
    • Written informed consent has been given
    • Capability and willingness to participate in the whole study

Exclusion Criteria:

  • • Liver disease (K70-77 in ICD10) or liver enzymes three times above upper reference range

    • Diabetic nephropathy (GFR < 30 mL/min/1.73 m2 or albuminuria) or other causes of renal disease
    • Proliferative diabetic retinopathy
    • Treatment with any glucose-lowering medication except metformin
    • Previous myocardial infarction, coronary heart disease or instable angina pectoris in the last 6 months.
    • Symptomatic heart failure (NYHA class II-III)
    • Previous surgery on the gastrointestinal tract
    • Larger surgical intervention during the last 12 weeks
    • Female subject who are pregnant or breast feeding
    • Women of child bearing potential not using a highly effective method of birth control
    • Treatment with oral steroids, thiazide diuretics, digoxin or growth hormone
    • Hypersensitivity to the active substances of to any of the excipients
    • Participation in another study the last 4 weeks
    • Smoker
    • Paracetamol intolerance
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 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 Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02089438
Other Study ID Numbers  ICMJE 200A
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bo Ahren, Lund University
Study Sponsor  ICMJE Lund University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bo Ahrén, MD, PhD Lund University
PRS Account Lund University
Verification Date August 2017

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