Investigation of safety and efficacy of five doses of NNC 0113-0217 versus placebo and open-label liraglutide, as add on therapy, in subjects diagnosed with type 2 diabetes currently treated with metformin or controlled with diet and exerciseA 12 week multi-centre, multi national, double-blind, placebo-controlled, randomised, nine armed parallel group, dose finding trial

Phase 1

• Conditions: type 2 diabetes mellitus; MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2007-003956-12-FR
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-08
• Study Completion: 2009-02-05
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 517

Inclusion Criteria

1.Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
2.Men and women-not-of-childbearing-potential diagnosed with type 2 diabetes for at least three months prior to trial
3.Men and women-not-of-childbearing-potential treated with diet and exercise alone, or who have been on stable doses of metformin (= 1500 mg) for at least three months prior to trial

The definition of women-not-of-childbearing-potential is: females who have been permanently sterilised (i.e. hysterectomy or bilateral oophorectomy), or who are postmenopausal (i.e. at least 6 months of spontaneous amenorrhoea with serum follicle stimulating hormone (FSH) >40 mU/mL.)

4.HbA1c: 7.0-10.0% (both inclusive)
5.Age =18 years, (as allowed according to local guidelines for metformin)
6.Body weight: 60.0 kg < body weight < 110.0 kg

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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

Exclusion Criteria

1. Treatment with insulin, GLP-1 receptor agonists (including liraglutide), DPP-4 inhibitors, sulphonylurea, thiazolidinediones or Alpha-GIs within the last three months prior to the trial (except for short-term treatment with insulin in connection with an intercurrent illness at the discretion of the Investigator)
2. Impaired liver function, defined as alanine aminotransferase (ALAT) = 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive)
3. Subjects known to be Hepatitis B antigen or Hepatitis C antibody positive
4. Impaired renal function defined as serum-creatinine = 135 µmol/L (=1.53 mg/dL) for males and = 120 µmol/L (= 1.23 mg/dL) for females (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive)
5. Proliferative retinopathy or maculopathy requiring acute treatment as judged by the Investigator
6. Clinically significant active cardiovascular disease including history of myocardial infarction within the past six months and/or heart failure (New York Heart Association (NYHA) class III and IV ) at the discretion of the Investigator.
7. Uncontrolled treated/untreated hypertension (systolic blood pressure = 160 mmHg and/or diastolic blood pressure =100 mmHg)
8. Cancer (past or present, except basal cell skin cancer or squamous cell skin cancer)
9. Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the Investigator.
10. Known or suspected allergy to trial product(s) or related products
11. Present or planned use of any drug (except for metformin), which in the Investigator’s opinion could interfere with the glucose levels (e.g. systemic cortisteroids)
12. The receipt of any investigational drug within three months prior to screening into this trial
13. Previous participation in the randomised phase of this trial. Re-screening is allowed once within the limits of the recruitment period.
14. Known or suspected abuse of alcohol or narcotics
15. Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation

Study & Design

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