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

• ClinicalTrials.gov Identifier: NCT02089438
• Recruitment Status: Completed
• First Posted: March 17, 2014
• Last Update Posted: August 23, 2017
• Sponsor: Lund University
• Information provided by (Responsible Party): Bo Ahren, Lund University

Tracking Information

• First Submitted Date: March 14, 2014
• First Posted Date: March 17, 2014
• Last Update Posted Date: August 23, 2017
• Study Start Date: May 2014
• Actual Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: DPP-4 Inhibition, Incretins and Islet Function
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Type 2 Diabetes

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 14, 2014): 24
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 2017
• Actual Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 40 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT02089438
• Other Study ID Numbers: 200A
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Bo Ahren, Lund University
• Study Sponsor: Lund University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Bo Ahrén, MD, PhD; Lund University

• PRS Account: Lund University
• Verification Date: August 2017