Study of the counter-regulation to hypoglycemia during treatment with sitagliptin in subjects with type 2 diabetes

Phase 1

• Conditions: Type 2 Diabetes Mellitus; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2014-002685-70-SE
• Lead Sponsor: und University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-18
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Written consent has been given.
2. Patients with metformin treated T2DM (metformin dose >=0.5/day and stable during the preceeding 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

1.Use of other glucose-lowering therapy than metformin within three months prior to visit 1.
2.A history of any secondary forms of diabetes, e.g., Cushing’s syndrome and acromegaly.
3.Type 2 diabetes, positive GAD antibodies
4.eGFR <60 ml/min
5.Acute infections which may affect blood glucose control within 4 weeks prior to visit 1
6.Any history of recent (<2 weeks) recurrent or severe hypoglycemic episodes.
7.Any history of acute pancreatitis
8.Any history of anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome.
9.Liver disease such as cirrhosis or chronic active hepatitis
10.History of coronary heart disease or heart failure class III or IV
11.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.
12.Treatment with growth hormone of chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1.
13.Use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study
14.Hypersensitivity to sitagliptin or any compound in the tablet core (microcrystalline cellulose (E460), calcium hydrogen phosphate, anhydrous (E341), croscarmellose sodium (E468), magnesium stearate (E470b) or sodium stearyl fumarate) or in the film coating (poly(vinyl alcohol), macrogol (E3350), talc (E553b), titanium dioxide (E171), red iron oxide (E172) or yellow iron oxide (E172))

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess if sitagliptin can improve the glucagon secretory response to mild hypoglycemia in elderly patients with metformin-treated type 2 diabetes.;Secondary Objective: To assess if sitagliptin can improve the cotisol, eipnephrine, norepinephrine and glucose counterregulatory responses to mild hypoglycemia in edlerly patients with metformin-treated T2DM.;Primary end point(s): The effect of sitagliptin on glucagon counter-regulation to hypoglycemia measured as ?glucagon (min 165-135) and ?glucagon (min 195-165);Timepoint(s) of evaluation of this end point: 4 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. The effect of sitagliptin compared to placebo on the counter-regulatory hormones cortisol, epinephrine and norepinephrine at the hypoglycemic clamp steps, determined as ? for these variables min 165-135 and 195-165, respectively, <br><br>2- The effect of sitagliptin compared to placebo on the insulin secretory rate estimated from the C-peptide responses and GLP-1 and GIP levels at the hypoglycemic clamp steps determined as ? for these variables min 165-135 and 195-165, respectively.<br>;Timepoint(s) of evaluation of this end point: 4 weeks