A trial in type 2 diabetes comparing NN9535 to placebo and liraglutide

Phase 2

Completed

• Conditions: Health Condition 1: E00-E07- Disorders of thyroid gland

• Registration Number: CTRI/2008/091/000031
• Lead Sponsor: ovo Nordisk AS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2009-02-03
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. Men and women-not-of-childbearing potential diagnosed with type 2 diabetes for at least three months

2. Stable treatment regimen with either metformin (at least 1500 mg) or diet and exercise alone for at least three months

3. HbA1c: 7.0-10.0 % (both inclusive)

4. Body weight between 60 kg and 110 kg

5.Age 18 years and above

Exclusion Criteria

1. Treatment with insulin, GLP-1 receptor agonists (including liraglutide), dipeptidyl peptidase-4 inhibitors, sulphonylurea, thiazolidinediones, Alpha-GIs, or any investigational drug, within the last three months
2. Impaired liver or kidney function
3. Proliferative retinopathy or maculopathy requiring acute treatment
4. Clinically significant active cardiovascular disease and uncontrolled treated/untreated hypertension
5. Recurrent major hypoglycaemia or hypoglycaemic unawareness
6. Present or planned use of any drug which could interfere with the glucose levels (e.g. systemic corticosteroids)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HbA1cTimepoint: 12 Weeks

Secondary Outcome Measures

Name	Time	Method
.Safety for the duration of the trial <br/ ><br>.â?¢Percentage of subjects with an adverse events. <br/ ><br>.â?¢Percentage of subjects with hypoglycaemic episode. <br/ ><br>.â?¢Change from baseline in ECG. <br/ ><br>.â?¢Change from baseline in vital signs (Pulse)(blood pressure). <br/ ><br>.â?¢Change from baseline in standard safety laboratory parameters (haematology)( biochemistry)(urinalysis). <br/ ><br>.â?¢Change from baseline in calcitonin. <br/ ><br> <br/ ><br>. <br/ ><br>.Timepoint: week 0, week 12;Antibodies for the duration of the trial<br>Timepoint: 12 Weeks