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Sitagliptin and Glucagon Counterregulation (SITACLAMP)

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ClinicalTrials.gov Identifier: NCT02256189
Recruitment Status : Completed
First Posted : October 3, 2014
Results First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Bo Ahren, Lund University

Brief Summary:
To evaluate the effect of DPP-4 inhibition on glucagon counter-regulatory mechanisms at moderate hypoglycemia in metformin-treated subjects with T2DM

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

Detailed Description:
The glucagon response to mild (3.0 mmol/l) hypoglycemia with and without DPP-4 inhibition by sitagliptin will be evaluated in elderly subjects with metformin treated type 2 diabetes to explore whether DPP-4 inhibition affects glucagon counter-regulation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Sitagliptin on Glucagon Counterregulation and Incretin Hormones During Mild Hypoglycemia in Elderly Patients With Metformin-treated Type 2 Diabetes
Actual Study Start Date : April 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arm Intervention/treatment
Sitagliptin first, then placebo
Sitagliptin treatment for four weeks, then washout for four weeks, then placebo for four weeks
Drug: Sitagliptin
Sitagliptin 100 mg daily

Placebo first, then sitagliptin
Placebo for four weeks, then washout for four weeks, then sitagliptin for four weeks
Drug: Placebo
Placebo one tablet daily




Primary Outcome Measures :
  1. Glucagon Counterregulation to Hypoglycemia [ Time Frame: Four weeks treatment ]
    Change in plasma glucagon to insulin-induced hypoglycemia after four weeks of treatment with sitagliptin and placebo



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written consent has been given.
  2. Patients with metformin treated T2DM (metformin dose >0,5 g/day and stable during the preceding 3 months)
  3. Age >65 years.
  4. HbA1c 6.0-8.5% (43-67 mmol/mol; inclusive) at visit 1.
  5. Ability to complete the study

Exclusion Criteria:

  1. A history of any secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.
  2. Type 2 diabetes, positive GAD antibodies
  3. eGFR <60 ml/min
  4. Acute infections which may affect blood glucose control within 4 weeks prior to visit 1
  5. Any history of recent (<2 weeks) recurrent or severe hypoglycemic episodes.
  6. Liver disease such as cirrhosis or chronic active hepatitis
  7. History of coronary heart disease or heart failure class III or IV
  8. Donation of one unit (500 ml) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks.
  9. Treatment with growth hormone of chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1.
  10. Use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study

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): NCT02256189


Locations
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Sweden
Skane University Hospital Malmö
Malmö, Sweden, 20502
Sponsors and Collaborators
Lund University
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Bo Ahrén, MD, PhD Lund University
  Study Documents (Full-Text)

Documents provided by Bo Ahren, Lund University:
Study Protocol  [PDF] December 12, 2015
Statistical Analysis Plan  [PDF] December 12, 2015

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Responsible Party: Bo Ahren, Professor, Lund University
ClinicalTrials.gov Identifier: NCT02256189    
Other Study ID Numbers: 300A
First Posted: October 3, 2014    Key Record Dates
Results First Posted: February 20, 2019
Last Update Posted: February 20, 2019
Last Verified: October 2018
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
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