A Study of Once-Daily NNC0090-2746 in Participants With Type 2 Diabetes Inadequately Controlled With Metformin
NCT ID: NCT02205528
Last Updated: 2020-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
108 participants
INTERVENTIONAL
2014-08-18
2015-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment Period: Placebo QD
Participants will receive daily SC placebo injections during the 12-week, double-blind treatment period.
Metformin
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
Matching placebo to NNC0090-2746 will be self-administered daily via SC injection.
Treatment Period: NNC0090-2746 QD
Participants will receive daily 1.8-mg SC injections of NNC0090-2746 during the 12-week, double-blind treatment period.
Metformin
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.
NNC0090-2746
NNC0090-2746 solution will be self-administered in daily doses of 1.8 mg via SC injection.
Treatment Period: Liraglutide QD
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.
Liraglutide
Liraglutide will be self-administered daily via SC injection according to manufacturer specifications.
Metformin
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.
Interventions
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Liraglutide
Liraglutide will be self-administered daily via SC injection according to manufacturer specifications.
Metformin
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
Matching placebo to NNC0090-2746 will be self-administered daily via SC injection.
NNC0090-2746
NNC0090-2746 solution will be self-administered in daily doses of 1.8 mg via SC injection.
Eligibility Criteria
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Inclusion Criteria
* Active diagnosis of T2D for greater than or equal to (\>/=) 3 months
* For females of childbearing potential and males with female partners of childbearing potential, agreement to use highly effective contraceptive measures
* Treated with a stable dose of metformin for at least 8 weeks prior to randomization, and expected to remain at the same stable dose throughout study participation
* Hemoglobin A1c (HbA1c) \>/= 7.2% and less than or equal to (\</=) 10.5%
* Fasting plasma glucose (FPG) less than (\<) 250 milligrams per deciliter (mg/dL)
* C-peptide greater than (\>) 1.5 nanograms per milliliter (ng/mL)
* Body mass index (BMI) \>/= 27 kilograms per meter-squared (kg/m\^2) and \</= 44 kg/m\^2
* Stable weight (+/- 5%) within 12 weeks prior to Screening
* Willing and able to maintain existing diet and exercise habits throughout the study
* Capable of performing SC self-injections on a daily basis during the study
Exclusion Criteria
* History of type 1 diabetes (T1D), diabetes resulting from pancreatic injury, or secondary forms of diabetes such as Cushing's Syndrome or acromegaly
* History of acute metabolic complications such as diabetic ketoacidosis or state of hyperosmolar hyperglycemia
* History of clinically significant diabetic complications such as diabetic proliferative retinopathy or severe diabetic neuropathy (requiring treatment with antidepressants or opioids)
* History of severe hypoglycemia within 6 months prior to Screening
* History of chronic gastrointestinal (GI) conditions that could impede gastric emptying or potentially affect the interpretation of the study data
* History of weight loss surgery or weight loss procedure involving the GI tract, such as gastric bypass, gastric stapling, or gastric banding
* History of an eating disorder (e.g., bulimia, anorexia)
* History of malignancy (except treated basal or squamous cell skin cancer) within 5 years prior to Screening
* Personal or family history of medullary thyroid carcinoma
* History of multiple endocrine neoplasia syndrome type 2
* History of chronic or acute pancreatitis or hemochromatosis
* History of significant cardiovascular disease (such as congestive heart failure New York Heart Association Class II to IV, myocardial infarction within the previous 6 months, coronary disease, or uncontrolled hypertension)
* History of clinically significant renal or liver disease
* History of hypersensitivity or previous intolerance to incretin or glucagon analogues
* Elevations in lipase or amylase levels at Screening \> 1.5 times the upper limit of normal (ULN) and considered clinically significant by the investigator
* Positive human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG), or hepatitis C antibody test at Screening
* Receipt of an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to Screening, or active enrollment in another investigational medication or device study
* Any condition, disorder, or abnormal laboratory test findings at screening that, in the judgment of the investigator, would interfere with the participant's ability to comply with all study requirements, or would require the administration of a treatment during the study that could potentially affect the interpretation of the study data, or would place the participant at unacceptable risk by his/her participation in the study
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR,1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Chino, California, United States
Novo Nordisk Investigational Site
Hawaiian Gardens, California, United States
Novo Nordisk Investigational Site
Los Angeles, California, United States
Novo Nordisk Investigational Site
Spring Valley, California, United States
Novo Nordisk Investigational Site
Hialeah, Florida, United States
Novo Nordisk Investigational Site
Port Orange, Florida, United States
Novo Nordisk Investigational Site
Sanford, Florida, United States
Novo Nordisk Investigational Site
Chicago, Illinois, United States
Novo Nordisk Investigational Site
Evanston, Illinois, United States
Novo Nordisk Investigational Site
Oxon Hill, Maryland, United States
Novo Nordisk Investigational Site
Berlin, New Jersey, United States
Novo Nordisk Investigational Site
Albuquerque, New Mexico, United States
Novo Nordisk Investigational Site
Greensboro, North Carolina, United States
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States
Novo Nordisk Investigational Site
Tulsa, Oklahoma, United States
Novo Nordisk Investigational Site
Eugene, Oregon, United States
Novo Nordisk Investigational Site
Knoxville, Tennessee, United States
Novo Nordisk Investigational Site
Corpus Christi, Texas, United States
Novo Nordisk Investigational Site
Houston, Texas, United States
Novo Nordisk Investigational Site
Manassas, Virginia, United States
Countries
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References
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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.
Other Identifiers
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U1111-1189-5627
Identifier Type: OTHER
Identifier Source: secondary_id
NN9709-4336
Identifier Type: -
Identifier Source: org_study_id
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