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DiabetesPhase 2NCT02205528

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

A Phase 2 study testing Liraglutide, Metformin and NNC0090-2746 in people with Diabetes and Diabetes Mellitus Type 2, run by Novo Nordisk A/S at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Diabetes, Diabetes Mellitus Type 2
What is being tested?
Liraglutide, Metformin and NNC0090-2746
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
108 participants
Where
20 sitesUnited States
Study dates
18 Aug 2014to 15 Sep 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Novo Nordisk Investigational Site

    Albuquerque, New Mexico, 87102

  • Novo Nordisk Investigational Site

    Berlin, New Jersey, 08009

  • Novo Nordisk Investigational Site

    Chicago, Illinois, 60607

  • Novo Nordisk Investigational Site

    Chino, California, 91710

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio, 45227

  • Novo Nordisk Investigational Site

    Corpus Christi, Texas, 78404

  • Novo Nordisk Investigational Site

    Eugene, Oregon, 97404

  • Novo Nordisk Investigational Site

    Evanston, Illinois, 60201

  • Novo Nordisk Investigational Site

    Greensboro, North Carolina, 27408

  • Novo Nordisk Investigational Site

    Hawaiian Gardens, California, 90716

  • Novo Nordisk Investigational Site

    Hialeah, Florida, 33012

  • Novo Nordisk Investigational Site

    Houston, Texas, 77074

  • Novo Nordisk Investigational Site

    Knoxville, Tennessee, 37920

  • Novo Nordisk Investigational Site

    Los Angeles, California, 90057

  • Novo Nordisk Investigational Site

    Manassas, Virginia, 20110

  • Novo Nordisk Investigational Site

    Oxon Hill, Maryland, 20745

  • Novo Nordisk Investigational Site

    Port Orange, Florida, 32127

  • Novo Nordisk Investigational Site

    Sanford, Florida, 32771

  • Novo Nordisk Investigational Site

    Spring Valley, California, 91978

  • Novo Nordisk Investigational Site

    Tulsa, Oklahoma, 74136

Other trials in United States

About this study

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

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.

Being tested
Liraglutide, Metformin, Placebo, NNC0090-2746
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LiraglutideDrug

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

  • MetforminDrug

    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.

  • PlaceboDrug

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

  • NNC0090-2746Drug

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

Study groups in NCT02205528
Study groupRoleWhat they receive
Treatment Period: Placebo QDPlacebo comparatorParticipants will receive daily SC placebo injections during the 12-week, double-blind treatment period.
Receives: Drug: Metformin; Drug: Placebo
Treatment Period: NNC0090-2746 QDExperimentalParticipants will receive daily 1.8-mg SC injections of NNC0090-2746 during the 12-week, double-blind treatment period.
Receives: Drug: Metformin; Drug: NNC0090-2746
Treatment Period: Liraglutide QDActive comparatorParticipants 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.
Receives: Drug: Liraglutide; Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c

    Measured: Day 1; Week 8

Secondary outcomes (9)

  1. Change in body weight

    Measured: Day 1; Week 8; Week 12

  2. Percent change in body weight

    Measured: Day 1; Week 8; Week 12

  3. Change in fasting plasma glucose (FPG)

    Measured: Day 1; Week 12

  4. Change in post-prandial plasma glucose level

    Measured: Day -7; Week 12

  5. Change in post-prandial insulin level

    Measured: Day -7; Week 12

  6. Change in post-prandial C-peptide level

    Measured: Day -7; Week 12

  7. Change in beta-cell function

    According to the Homeostasis Model Assessment (HOMA) score

    Measured: Day 1; Week 12

  8. Incidence of treatment-emergent adverse events

    Measured: Day 1; Week 18

  9. Change in percent HbA1c

    Measured: Day 1; Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2014 (estimated)
  2. Study start18 Aug 2014
  3. Primary completion15 Sep 2015
  4. Study completion15 Sep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02205528
Sponsor's protocol ID
NN9709-4336
Other IDs
U1111-1189-5627
Status last verified
Jul 2020
First submitted
30 Jul 2014
Last updated
21 Jul 2020
Results posted
No

Publications

  • 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.

    PubMed 28768173

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Liraglutide, Metformin and NNC0090-2746 in people with Diabetes and Diabetes Mellitus Type 2, run by Novo Nordisk A/S at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: Day 1; Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02205528, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.

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