Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1189-5627 | Other Identifier | World Health Organization (WHO) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is conducted in the United States of America (USA). The aim of the trial is to investigate the efficacy, safety, and tolerability of once-daily subcutaneous (SC) injections of NNC0090-2746 for 12 weeks, as an adjunct to metformin, in participants with T2D.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Period: Placebo QD | Placebo Comparator | Participants will receive daily SC placebo injections during the 12-week, double-blind treatment period. |
|
| Treatment Period: NNC0090-2746 QD | Experimental | Participants will receive daily 1.8-mg SC injections of NNC0090-2746 during the 12-week, double-blind treatment period. |
|
| Treatment Period: Liraglutide QD | Active Comparator | Participants will receive open-label liraglutide via SC injection during the 12-week treatment period. The dose scheme will be as follows: 0.6 milligrams (mg) each day during Week 1, followed by 1.2 mg each day during Week 2, and 1.8 mg each day from Weeks 3 to 12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide | Drug | Liraglutide will be self-administered daily via SC injection according to manufacturer specifications. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Day 1; Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Day 1; Week 8; Week 12 | |
| Percent change in body weight | Day 1; Week 8; Week 12 | |
| Change in fasting plasma glucose (FPG) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR,1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Chino | California | 91710 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28768173 | Result | Frias JP, Bastyr EJ 3rd, Vignati L, Tschop MH, Schmitt C, Owen K, Christensen RH, DiMarchi RD. The Sustained Effects of a Dual GIP/GLP-1 Receptor Agonist, NNC0090-2746, in Patients with Type 2 Diabetes. Cell Metab. 2017 Aug 1;26(2):343-352.e2. doi: 10.1016/j.cmet.2017.07.011. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Metformin | Drug | Metformin hydrochloride immediate- or extended-release oral tablets will be supplied by the participant or investigational site as standard-of-care treatment beginning at least 8 weeks prior to randomization and throughout the 12-week treatment period. Metformin will also be continued during the 4-week follow-up. Dose selection will be based upon manufacturer specifications. |
|
| Placebo | Drug | Matching placebo to NNC0090-2746 will be self-administered daily via SC injection. |
|
| NNC0090-2746 | Drug | NNC0090-2746 solution will be self-administered in daily doses of 1.8 mg via SC injection. |
|
| Day 1; Week 12 |
| Change in post-prandial plasma glucose level | Day -7; Week 12 |
| Change in post-prandial insulin level | Day -7; Week 12 |
| Change in post-prandial C-peptide level | Day -7; Week 12 |
| Change in beta-cell function | According to the Homeostasis Model Assessment (HOMA) score | Day 1; Week 12 |
| Incidence of treatment-emergent adverse events | Day 1; Week 18 |
| Change in percent HbA1c | Day 1; Week 12 |
| Hawaiian Gardens |
| California |
| 90716 |
| United States |
| Novo Nordisk Investigational Site | Los Angeles | California | 90057 | United States |
| Novo Nordisk Investigational Site | Spring Valley | California | 91978 | United States |
| Novo Nordisk Investigational Site | Hialeah | Florida | 33012 | United States |
| Novo Nordisk Investigational Site | Port Orange | Florida | 32127 | United States |
| Novo Nordisk Investigational Site | Sanford | Florida | 32771 | United States |
| Novo Nordisk Investigational Site | Chicago | Illinois | 60607 | United States |
| Novo Nordisk Investigational Site | Evanston | Illinois | 60201 | United States |
| Novo Nordisk Investigational Site | Oxon Hill | Maryland | 20745 | United States |
| Novo Nordisk Investigational Site | Berlin | New Jersey | 08009 | United States |
| Novo Nordisk Investigational Site | Albuquerque | New Mexico | 87102 | United States |
| Novo Nordisk Investigational Site | Greensboro | North Carolina | 27408 | United States |
| Novo Nordisk Investigational Site | Cincinnati | Ohio | 45227 | United States |
| Novo Nordisk Investigational Site | Tulsa | Oklahoma | 74136 | United States |
| Novo Nordisk Investigational Site | Eugene | Oregon | 97404 | United States |
| Novo Nordisk Investigational Site | Knoxville | Tennessee | 37920 | United States |
| Novo Nordisk Investigational Site | Corpus Christi | Texas | 78404 | United States |
| Novo Nordisk Investigational Site | Houston | Texas | 77074 | United States |
| Novo Nordisk Investigational Site | Manassas | Virginia | 20110 | United States |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
Not provided
Not provided