Sitagliptin and Glucagon Counterregulation

Type 2 Diabetes Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02256189
• Other study ID #: 300A
• Status: Completed
• Phase: Phase 4
• Start date: April 2015
• Est. completion date: June 2017

Study information

• Verified date: October 2018
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Sitagliptin
Sitagliptin 100 mg daily
• Placebo
Placebo one tablet daily

Locations

Country	Name	City	State
Sweden	Skane University Hospital Malmö	Malmö

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucagon Counterregulation to Hypoglycemia	Change in plasma glucagon to insulin-induced hypoglycemia after four weeks of treatment with sitagliptin and placebo	Four weeks treatment