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Completed

NCT Number: NCT02205528

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, Chino, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

Liraglutide will be self-administered daily via SC injection according to manufacturer specifications.

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.

Primary outcomes

  1. Change in HbA1c

    Time frame: Day 1; Week 8

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 31, 2014
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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