Diabetes Mellitus, Type 2 MedDRA version: 17.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Product Code: 0123-0338 B 900nmol tablet
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: N/A
Current Sponsor code: NNC0123-0338
Other descriptive name: Insulin 338
Concentration unit: nmo
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subject 2. Age of 18–70 years (both inclusive) at the time of signing informed consent 3. Body mass index of 25.0–40.0 kg/m^2 (both inclusive) 4. Subject diagnosed (clinically) with type 2 diabetes mellitus for =180 days prior to the day of screening 5. Insulin naïve subject; however, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes 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 44 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: 1. Known or suspected hypersensitivity to the trial products or related products 2. Any disorder which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol 3. Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the glycaemic control after 8 weeks of treatment with oral insulin 338 in a GIPET® I tablet formulation versus subcutaneous insulin glargine, when both are administered once daily in combination with metformin ± DPP-4 inhibitor in subjects with type 2 diabetes inadequately controlled on oral antidiabetic therapy;Secondary Objective: 1. To compare the safety and tolerability during 8 weeks of treatment with oral insulin 338 in a GIPET® I tablet formulation versus subcutaneous insulin glargine, when both are administered once daily in combination with metformin ± DPP-4 inhibitor in subjects with type 2 diabetes 2. To investigate the pharmacokinetics of oral insulin 338 in a GIPET® I tablet formulation and subcutaneous insulin glargine during 8 weeks of treatment in subjects with type 2 diabetes ;Primary end point(s): Fasting plasma glucose;Timepoint(s) of evaluation of this end point: After 8 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. 10-point plasma glucose profile measured at pre-dose, before and after breakfast, lunch, main evening meal, at bedtime, at 04:00 in the morning and pre-dose on the following day 2. Number of treatment emergent hypoglycaemic episodes 3. AUCIns,t,SS, area under the serum insulin concentration-time curve ;Timepoint(s) of evaluation of this end point: 1. After 8 weeks of treatment 2. From start of treatment until Visit 14 (Day 68) 3. During one dosing interval (0 to 24 hours) at steady state (Day 56) | — |
Countries
Germany
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed