Diabetes Mellitus, type 2 MedDRA version: 21.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Lantus SoloStar
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin glargine
CAS Number: 160337-95-1
Other descriptive name: INSULIN GLARGINE
Concentration unit: U/ml
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosed with T2D mellitus greater than or equal to 180 days before screening. - HbA1c of 7-10% (53-86 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening. - Body mass index (BMI) greater than or equal to 25 kg/m^2 on the day of screening. - Stable daily dose(s) greater than or equal to 90 days before screening of any of the following anti-diabetic drugs or combination regimens: - Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. - Any metformin combination formulation greater than or equal to 1500 mg or maximum tolerated or effective dose. The treatment can be with or without SGLT-2 inhibitors. - Treated with a once daily basal insulin (e.g. insulin glargine U100 or U300, NPH insulin, insulin detemir, insulin degludec) less than or equal to 40 U/day for greater than or equal to 90 days before screening. Short term bolus insulin treatment for a maximum of 14 days before screening is allowed. 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 324 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 244
Exclusion criteria
Exclusion criteria: - Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. - Potentially missed diagnosis of Type 1 diabetes (T1D) or latent autoimmune diabetes in adults (LADA) verified by C-peptide less than 0.26 pmol/L or 260 pmol/L (0.78 ng/mL) or antibodies to glutamic acid decarboxylase (anti-GAD) greater than 5 units/mL, as measured by the central laboratory at screening. - Presence or history(a) of pancreatitis (acute or chronic). - Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 30 mL/min/1.73 m2 at screening as defined by KDIGO 2012 classification. - Any episodes(a) of diabetic ketoacidosis within 90 days before screening. - Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question. (a) As declared by the participant or in the medical records
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm that efficacy as measured by change from baseline to week 40 in HbA1c (% point) of OW semaglutide s.c. 2.0 mg as add-on to dose reduced insulin glargine U100 is not unacceptably worse (i.e., noninferior) to that of titrated insulin glargine U100 on change from baseline to week 40 in HbA1c (%-point) in participants with T2D and overweight treated with 40 units or less of basal insulin per day. Noninferiority is assessed based on the clinically acceptable margin of 0.3%-point for the mean treatment difference in HbA1c.;Secondary Objective: 1. To confirm superiority of OW semaglutide s.c. 2.0 mg as add-on to dose-reduced insulin glargine U100 versus titrated insulin U100 on: a. change from baseline to week 40 in body weight (kg) and HbA1c (%) in participants with T2D and overweight treated with 40 units or less of basal insulin per day. b. change from baseline to week 40 in DTSQc score in participants with T2D and overweight treated with 40 units or less of basal insulin per day. c. relative change from baseline to week 40 in daily insulin dose (%) in participants with T2D and overweight treated with 40 units or less of basal insulin per day. 2. To compare the effect of OW semaglutide s.c. 2.0 mg as add-on to dose-reduced insulin glargine U100 versus titrated insulin glargine U100 on insulin requirements, glycaemic control, hypoglycaemia, and patient reported outcome in participants with T2D and overweight treated with 40 units or less of basal insulin per day.;Primary end point(s): 1. Change in HbA1c;Timepoint(s) of evaluation of this end point: 1. From baseline (week 0) to end of treatment (week 40) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in body weight 2 Relative change in daily insulin dose 3. Change in HbA1c 4. Score of Diabetes Treatment Satisfaction Questionnaire – change version (DTSQc) 5. Participants achieving: Insulin dose = 0 U 6. Participants achieving: Insulin dose reduced from baseline by at least 50% 7. Participants achieving: HbA1c < 7% 8. Number of severe hypoglycaemic episodes (level 3) 9. Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL) confirmed by BG meter) 10. Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) 11. Participants achieving all of the following targets: - HbA1c reduced from baseline by at least 0.3%-points - Insulin dose reduced from baseline - No hypoglycaemic episodes (< 3.9 mmol/L (70 mg/dL) confirmed by BG meter) - No weight gain 12. Change in score of Diabetes Treatment Satisfaction Questionnaire – status version (DTSQs);Timepoint(s) of evaluation of this end point: 1.-3, 8-10. From baseline (week 0) to end of treatment (week 40) 4.-7, 11-12. At end of treatment (week 40) | — |
Countries
European Union, Greece, Italy, Portugal, Russian Federation, Slovakia, South Africa, Spain, Ukraine, United States
Contacts
Public ContactClinical Transparency (2834)
Novo Nordisk A/S
Outcome results
None listed