A research study to look into how well semaglutide medicine works at different doses in people with type 2 diabetes and overweight

Phase 1

• Conditions: Diabetes Mellitus, Type 2Overweight; MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 24.1Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2022-000882-41-HU
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-03
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

- Male or female.
- Aged 18-64 years (both inclusive) at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening.
- HbA1c (glycated haemoglobin) of 7.0 – 10.5% (53 – 91 mmol/mL) (both inclusive).
- BMI (Body Mass Index) greater than or equal to 27.0 kg/m2.
- Stable daily dose(s) greater than or equal to 90 days prior to the day of screening of any metformin formulations.
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 240
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. 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.

- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to day of 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.

- Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than 30 mL/min/1.73 m2 at screening.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To characterise the dose-response curve of once-weekly semaglutide s.c. for change in HbA1c from baseline to week 40 in patients with T2D and BMI = 27 kg/m2 as an add-on to a stable dose of metformin;Secondary Objective: - To characterise the dose-response curve of once-weekly semaglutide s.c. for change in body weight from baseline to week 40 in patients with T2D and BMI = 27 kg/m2 as an add-on to a stable dose of metformin<br><br>- To characterise the dose-response curve of once-weekly semaglutide s.c. for safety and tolerability from baseline to week 49 in patients with T2D and BMI = 27 kg/m2 as an add-on to a stable dose of metformin;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 Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Change in body weight<br>2. Number of treatment-emergent adverse events (TEAEs)<br>3. Number of treatment-emergent severe hypoglycaemic episodes;Timepoint(s) of evaluation of this end point: 1. From baseline (week 0) to end of treatment (week 40)<br>2.-3. From baseline (week 0) to end of study (week 49)