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A Study of Once-Daily NNC0090-2746 in Participants With Type 2 Diabetes Inadequately Controlled With Metformin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02205528
Recruitment Status : Completed
First Posted : July 31, 2014
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus Type 2 Drug: Liraglutide Drug: Metformin Drug: Placebo Drug: NNC0090-2746 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Phase 2a Study With an Open-Label Active Group to Assess the Efficacy and Safety of Once-Daily NNC0090-2746 in Type 2 Diabetic Patients Inadequately Controlled With Metformin
Actual Study Start Date : August 18, 2014
Actual Primary Completion Date : September 15, 2015
Actual Study Completion Date : September 15, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Treatment Period: Placebo QD
Participants will receive daily SC placebo injections during the 12-week, double-blind treatment period.
Drug: 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.

Drug: Placebo
Matching placebo to NNC0090-2746 will be self-administered daily via SC injection.

Experimental: 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.
Drug: 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.

Drug: NNC0090-2746
NNC0090-2746 solution will be self-administered in daily doses of 1.8 mg via SC injection.

Active Comparator: 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.
Drug: Liraglutide
Liraglutide will be self-administered daily via SC injection according to manufacturer specifications.

Drug: 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.




Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: Day 1; Week 8 ]

Secondary Outcome Measures :
  1. Change in body weight [ Time Frame: Day 1; Week 8; Week 12 ]
  2. Percent change in body weight [ Time Frame: Day 1; Week 8; Week 12 ]
  3. Change in fasting plasma glucose (FPG) [ Time Frame: Day 1; Week 12 ]
  4. Change in post-prandial plasma glucose level [ Time Frame: Day -7; Week 12 ]
  5. Change in post-prandial insulin level [ Time Frame: Day -7; Week 12 ]
  6. Change in post-prandial C-peptide level [ Time Frame: Day -7; Week 12 ]
  7. Change in beta-cell function [ Time Frame: Day 1; Week 12 ]
    According to the Homeostasis Model Assessment (HOMA) score

  8. Incidence of treatment-emergent adverse events [ Time Frame: Day 1; Week 18 ]
  9. Change in percent HbA1c [ Time Frame: Day 1; Week 12 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants aged 18 to 70 years, inclusive
  • 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:

  • Females who are pregnant or lactating
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02205528


Locations
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United States, California
Novo Nordisk Investigational Site
Chino, California, United States, 91710
Novo Nordisk Investigational Site
Hawaiian Gardens, California, United States, 90716
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90057
Novo Nordisk Investigational Site
Spring Valley, California, United States, 91978
United States, Florida
Novo Nordisk Investigational Site
Hialeah, Florida, United States, 33012
Novo Nordisk Investigational Site
Port Orange, Florida, United States, 32127
Novo Nordisk Investigational Site
Sanford, Florida, United States, 32771
United States, Illinois
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60607
Novo Nordisk Investigational Site
Evanston, Illinois, United States, 60201
United States, Maryland
Novo Nordisk Investigational Site
Oxon Hill, Maryland, United States, 20745
United States, New Jersey
Novo Nordisk Investigational Site
Berlin, New Jersey, United States, 08009
United States, New Mexico
Novo Nordisk Investigational Site
Albuquerque, New Mexico, United States, 87102
United States, North Carolina
Novo Nordisk Investigational Site
Greensboro, North Carolina, United States, 27408
United States, Ohio
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45227
United States, Oklahoma
Novo Nordisk Investigational Site
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Novo Nordisk Investigational Site
Eugene, Oregon, United States, 97404
United States, Tennessee
Novo Nordisk Investigational Site
Knoxville, Tennessee, United States, 37920
United States, Texas
Novo Nordisk Investigational Site
Corpus Christi, Texas, United States, 78404
Novo Nordisk Investigational Site
Houston, Texas, United States, 77074
United States, Virginia
Novo Nordisk Investigational Site
Manassas, Virginia, United States, 20110
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR,1452) Novo Nordisk A/S
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02205528    
Other Study ID Numbers: NN9709-4336
U1111-1189-5627 ( Other Identifier: World Health Organization (WHO) )
First Posted: July 31, 2014    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists