type 2 diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Product Name: NNC 0113-0217
Pharmaceutical Form: Solution for injection
INN or Proposed INN: NNC 0113-0217
Current Sponsor code: NN9535
Other descriptive name: NNC 0113-0217
Concentration unit: mg/ml
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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: 1. females who have been permanently sterilised (i.e. hysterectomy or bilateral oophorectomy), or 2. who are postmenopausal (i.e. at least 12 months of spontaneous amenorrhoea with serum follicle stimulating hormone (FSH) >40 mIU/mL (preferably measured at three times separated by several weeks) and oestrogen deficiency (estradiol levels =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To assess and compare the dose-response of five doses (6 treatment arms) of NNC 0113-0217 versus placebo on glycaemic control in the treatment of type 2 diabetes as assessed by change from baseline to end of treatment in HbA1c.;Secondary Objective: To assess and compare the effect on: • change from baseline to end of treatment in HbA1c of five dose levels (6 treatment arms) of NNC 0113-0217 versus 2 doses of open label liraglutide • additional glycaemic control parameters (Homeostasis model assessment (HOMA ), fasting plasma glucose (FPG), insulin, C-peptide, insulin/pro-insulin ratio, and glucagon) • change from baseline to end of treatment in body weight • change from baseline to end of treatment in waist and hip circumference •To assess and compare lipid profiles: total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), very low density lipoprotein cholesterol (VLDL-C), high density lipoprotein cholesterol (HDL-C) and triglyceride (TG)) •To assess and compare the subjective feelings of appetite following a standard meal •To assess and compare postprandial plasma glucose, insulin and C-peptide levels •To assess and compare rates of gastric emptying as assessed by paracetamol kinetics ;Primary end point(s): •Change in HbA1c from baseline to end of treatment | — |
Countries
Austria, Bulgaria, Finland, France, Germany, Hungary, Italy, United Kingdom
Outcome results
None listed