A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 Diabetes
Purpose
This study is being done to look at the effect and safety of different doses of NNC0662-0419 in people living with type 2 diabetes when compared to placebo or semaglutide. The purpose of this clinical study is to find out if NNC0662-0419 is effective and safe for treating people living with type 2 diabetes. Participants will get either NNC0662-0419, semaglutide or placebo. Which treatment participants get is decided by chance. NNC0662-0419 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Semaglutide is an approved medication to treat type 2 diabetes.
Condition
- Diabetes Mellitus, Type 2
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male or female (sex at birth). - Age 18-75 years (both inclusive) at the time of signing the informed consent. - Glycated haemoglobin (HbA1c) of 7.0-10.0 percent (%) (53-86 millimoles per mole [mmol/mol]) (both inclusive) as assessed by central laboratory at screening. - Willingness to obtain a high weight loss (greater than [>] 25% of weight at baseline).
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 consecutive days and prior insulin treatment for gestational diabetes are allowed. - Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. - Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's Questionnaire.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental NNC0662-0419 |
Participants will receive NNC0662-0419 subcutaneously (s.c.) in a dose escalating manner once weekly. |
|
|
Active Comparator Semaglutide |
Participants will receive semaglutide s.c. once weekly. |
|
|
Placebo Comparator Placebo |
Participants will receive placebo matched to their respective investigational medicinal product s.c. once weekly. |
|
Recruiting Locations
First Valley Medical Group
Lancaster, California 93534
Lancaster, California 93534
Torrance Clinical Research Institute, Inc.
Lomita, California 90717
Lomita, California 90717
Ark Clinical Research
Long Beach, California 90815
Long Beach, California 90815
Pacific Clinical Studies
Los Alamitos, California 90720
Los Alamitos, California 90720
Wetlin Research Associates, Inc.
San Diego, California 92120
San Diego, California 92120
Diablo Clinical Research, Inc.
Walnut Creek, California 94598
Walnut Creek, California 94598
Encore Medical Research LLC
Hollywood, Florida 33024
Hollywood, Florida 33024
Bioclinical Research Alliance
Miami, Florida 33155
Miami, Florida 33155
South Broward Research LLC
Miramar, Florida 33027
Miramar, Florida 33027
Encore Medical Research of Weston
Weston, Florida 33331
Weston, Florida 33331
Elite Clinical Trials
Blackfoot, Idaho 83221
Blackfoot, Idaho 83221
Cedar-Crosse Research Center
Chicago, Illinois 60607
Chicago, Illinois 60607
Headlands Research
Springfield, Missouri 65807
Springfield, Missouri 65807
PharmQuest
Greensboro, North Carolina 27408
Greensboro, North Carolina 27408
Piedmont Healthcare Statesville
Statesville, North Carolina 28625
Statesville, North Carolina 28625
Providence Center for Clinical Research
Dayton, Ohio 45439
Dayton, Ohio 45439
CNS Healthcare
Memphis, Tennessee 38119
Memphis, Tennessee 38119
University of Texas Southwestern Medical Center
Dallas, Texas 75390-9302
Dallas, Texas 75390-9302
JCCT- Juno NW Houston
Houston, Texas 77040
Houston, Texas 77040
Consano Clinical Research, LLC
Shavano Park, Texas 78231
Shavano Park, Texas 78231
More Details
- Status
- Recruiting
- Sponsor
- Novo Nordisk A/S