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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

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Saxagliptin Drug: Vildagliptin Drug: Sitagliptin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Comparison of Three DPP-4 Inhibitors on 24 Hour Blood Glucose, Incretin Hormones and Islet Function in Patients With Type 2 Diabetes
Study Start Date : May 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Saxagliptin
Ssaxagliptin is given before breakfast
Drug: Saxagliptin
Saxagliptin (5 mg) is given before breakfast
Other Name: Onglyza

Experimental: ´Sitagliptin
Sitagliptin is given before breakfast
Drug: Sitagliptin
Sitagliptin (100 mg) is given before breakfast
Other Name: Januvia

Experimental: Vildagliptin
Vildagliptin is given before breakfast
Drug: Vildagliptin
Vildagliptin (50mg) is given before breakfast and dinner
Other Name: Galvus




Primary Outcome Measures :
  1. Postprandial glucose [ Time Frame: 180 min ]
    The area under the 180 min curves for plasma glucose after each meal


Secondary Outcome Measures :
  1. Postprandial insulin and glucagon [ Time Frame: 180 min ]
    The area under the 180 min curves for plasma insulin and glucagon after each meal

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089438


Locations
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Sweden
Clinical Research Department
Lund, Sweden, 22185
Sponsors and Collaborators
Lund University
Investigators
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Principal Investigator: Bo Ahrén, MD, PhD Lund University
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Responsible Party: Bo Ahren, Professor, Lund University
ClinicalTrials.gov Identifier: NCT02089438    
Other Study ID Numbers: 200A
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Saxagliptin
Vildagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action