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Trial record 28 of 10795 for:    Placebo AND once

Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02461589
Recruitment Status : Completed
First Posted : June 3, 2015
Results First Posted : January 23, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted globally. The aim of this trial is to investigate dose-finding of semaglutide administered subcutaneously once daily versus placebo and liraglutide in subjects with type 2 diabetes

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: semaglutide Drug: liraglutide Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 706 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes
Actual Study Start Date : September 21, 2015
Actual Primary Completion Date : October 13, 2016
Actual Study Completion Date : October 13, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Semaglutide 0.05 mg/day Drug: semaglutide
Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen except subjects who received semaglutide flexible dosing.

Active Comparator: Liraglutide 0.3 mg/day Drug: liraglutide
Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen.

Placebo Comparator: Placebo 50 µL Drug: placebo
Administered subcutaneously ( s.c., under the skin) once daily.

Experimental: Semaglutide 0.05/0.1 mg/day Drug: semaglutide
Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen except subjects who received semaglutide flexible dosing.

Active Comparator: Liraglutide 0.3/0.6 mg/day Drug: liraglutide
Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen.

Placebo Comparator: Placebo 50/100 µL Drug: placebo
Administered subcutaneously ( s.c., under the skin) once daily.

Experimental: Semaglutide 0.05/0.1/0.2 mg/day Drug: semaglutide
Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen except subjects who received semaglutide flexible dosing.

Active Comparator: Liraglutide 0.3/0.6/1.2 mg/day Drug: liraglutide
Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen.

Placebo Comparator: Placebo 50/100/200 µL Drug: placebo
Administered subcutaneously ( s.c., under the skin) once daily.

Experimental: Semaglutide 0.05/0.1/0.2/0.3 mg/day Drug: semaglutide
Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen except subjects who received semaglutide flexible dosing.

Active Comparator: Liraglutide 0.3/0.6/1.2/1.8 mg/day Drug: liraglutide
Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen.

Placebo Comparator: Placebo 50/100/200/300 µL Drug: placebo
Administered subcutaneously ( s.c., under the skin) once daily.

Experimental: Semaglutide flexible escalation from 0.05 mg/day to 0.3 mg/day Drug: semaglutide
Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen except subjects who received semaglutide flexible dosing.




Primary Outcome Measures :
  1. Change in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, week 26 ]
    Estimated mean change from baseline in HbA1c at week 26. The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.


Secondary Outcome Measures :
  1. Change in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, Week 26 ]
    Estimated mean change from baseline in FPG at week 26. The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.

  2. Body Weight Change [ Time Frame: Week 0, Week 26 ]
    The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.

  3. Change in Systolic and Diastolic Blood Pressure [ Time Frame: Week 0, Week 26 ]
    The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, age at least 18 years at the time of signing informed consent.
  • Subjects should be on stable diabetes treatment consisting of diet and exercise with or without metformin (at least 1500 mg daily or maximum tolerated dose documented in the patient medical record) for at least 90 days prior to screening
  • HbA1c (glycosylated haemoglobin): 53-86 mmol/mol (7.0-10.0%) (both inclusive)
  • BMI: 25.0 - 40.0 kg/m^2 (both inclusive)

Exclusion Criteria:

  • Simultaneous participation in any other clinical trial of an investigational medicinal product
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods throughout the trial including the 7 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). Germany: Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. United Kingdom: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), female sterilisation, male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle)
  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening (an exception is short-term insulin treatment for acute illnesses for a total of below or equal to 14 days)
  • Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on an frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
  • History of pancreatitis (acute or chronic)
  • Screening calcitonin above or equal to 50 ng/L
  • Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)
  • Severe to moderate renal impairment defined as GFR, estimated below 60 ml/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology)
  • Within the past 180 days before screening any of the following: Myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack
  • Currently planned coronary, carotid or peripheral artery revascularisation
  • Patients presently classified as being in New York Heart Association (NYHA) Class III or IV

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): NCT02461589


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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02461589     History of Changes
Other Study ID Numbers: NN9535-4191
2014-003196-39 ( EudraCT Number )
U1111-1159-4923 ( Other Identifier: WHO )
First Posted: June 3, 2015    Key Record Dates
Results First Posted: January 23, 2018
Last Update Posted: September 10, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists