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Sitagliptin and Glucagon Counterregulation (SITACLAMP)

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Sitagliptin
Placebo
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Skane University Hospital Malmö

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Sitagliptin first, then placebo

Placebo first, then sitagliptin

Arm Description

Sitagliptin treatment for four weeks, then washout for four weeks, then placebo for four weeks

Placebo for four weeks, then washout for four weeks, then sitagliptin for four weeks

Outcomes

Primary Outcome Measures

Glucagon Counterregulation to Hypoglycemia
Change in plasma glucagon to insulin-induced hypoglycemia after four weeks of treatment with sitagliptin and placebo

Secondary Outcome Measures

Full Information

First Posted
September 29, 2014
Last Updated
October 14, 2018
Sponsor
Lund University
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02256189
Brief Title
Sitagliptin and Glucagon Counterregulation
Acronym
SITACLAMP
Official Title
The Effect of Sitagliptin on Glucagon Counterregulation and Incretin Hormones During Mild Hypoglycemia in Elderly Patients With Metformin-treated Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sitagliptin first, then placebo
Arm Type
Other
Arm Description
Sitagliptin treatment for four weeks, then washout for four weeks, then placebo for four weeks
Arm Title
Placebo first, then sitagliptin
Arm Type
Other
Arm Description
Placebo for four weeks, then washout for four weeks, then sitagliptin for four weeks
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Intervention Description
Sitagliptin 100 mg daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo one tablet daily
Primary Outcome Measure Information:
Title
Glucagon Counterregulation to Hypoglycemia
Description
Change in plasma glucagon to insulin-induced hypoglycemia after four weeks of treatment with sitagliptin and placebo
Time Frame
Four weeks treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written consent has been given. Patients with metformin treated T2DM (metformin dose >0,5 g/day and stable during the preceding 3 months) Age >65 years. HbA1c 6.0-8.5% (43-67 mmol/mol; inclusive) at visit 1. Ability to complete the study Exclusion Criteria: A history of any secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly. Type 2 diabetes, positive GAD antibodies eGFR <60 ml/min Acute infections which may affect blood glucose control within 4 weeks prior to visit 1 Any history of recent (<2 weeks) recurrent or severe hypoglycemic episodes. Liver disease such as cirrhosis or chronic active hepatitis History of coronary heart disease or heart failure class III or IV 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. Treatment with growth hormone of chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1. Use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Ahrén, MD, PhD
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skane University Hospital Malmö
City
Malmö
ZIP/Postal Code
20502
Country
Sweden

12. IPD Sharing Statement

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Sitagliptin and Glucagon Counterregulation

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