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Efficacy and Safety of Metformin and Liraglutide in Obese Subjects With Type 2 Diabetes Previously Treated With an Oral Hypoglycemic Agent

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT01511198
Collaborator
(none)
223
Enrollment
39
Locations
6
Arms
8
Duration (Months)
5.7
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to determine the dose-response relationship for body weight and five escalating doses of NNC 90-1170 (liraglutide) in subjects with type 2 diabetes previously treated with an oral hypoglycemic agent (OHA).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
223 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
NNC 90-1170 Dose-response, Efficacy and Safety: A 12-week Randomized, Multicenter, Doubleblind, Double-dummy, Parallel-group Study of Metformin and Five Doses of NNC 90-1170 in Previously-treated OHA Monotherapy Obese Subjects With Type 2 Diabetes
Study Start Date :
Feb 1, 2001
Actual Primary Completion Date :
Oct 1, 2001
Actual Study Completion Date :
Oct 1, 2001

Arms and Interventions

Arm Intervention/Treatment
Experimental: 0.045 mg

Drug: liraglutide
Injected subcutaneously once daily
Other Names:
  • NNC 90-1170

    		•
    Experimental: 0.225 mg

    Drug: liraglutide
    Injected subcutaneously once daily
    Other Names:
  • NNC 90-1170

    		•
    Experimental: 0.45 mg

    Drug: liraglutide
    Injected subcutaneously once daily
    Other Names:
  • NNC 90-1170

    		•
    Experimental: 0.60 mg

    Drug: liraglutide
    Injected subcutaneously once daily
    Other Names:
  • NNC 90-1170

    		•
    Experimental: 0.75 mg

    Drug: liraglutide
    Injected subcutaneously once daily
    Other Names:
  • NNC 90-1170

    		•
    Active Comparator: Met

    Drug: metformin
    1000 mg twice daily, administered orally

    Outcome Measures

    Primary Outcome Measures

    1. Body weight []

    Secondary Outcome Measures

    1. FPG (fasting plasma glucose) []

    2. HbA1c (glycosylated haemoglobin) []

    3. Fructosamine []

    4. Lipids []

    5. Adverse events []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Type 2 diabetic

    • Treated with OHA (oral hypoglycaemic agent monotherapy for at least 3 months. Prior use of metformin is allowed

    • Body Mass Index (BMI) between 27.0-42.0 kg/m^2 (inclusive)

    • HbA1c maximum 10% based on analysis from central laboratory

    Exclusion Criteria:

    • Cardiac problems

    • Uncontrolled treated/untreated hypertension

    • Proliferative retinopathy or known autonomic neuropathy

    • Recurrent severe hypoglycemia as judged by the investigator

    • Known or suspected allergy to trial product or related products

    • Use of any drug (except for OHAs), which in the investigators opinion could interfere with the glucose level or body weight or any contraindication to metformin use or intolerance to metformin 1000 mg (prior to trial entry or during run-in period). Stable doses, for 3 months or greater, of thyroid hormone replacement are allowed

    • Known or suspected abuse of alcohol or narcotics

    • Current treatment with thiazolidinediones or chronic daily use of insulin (more than 7 days) within three months in the absence of intercurrent illness

    • TSH (thyroid stimulating hormone) below 0.2 or above 15 U/mL

    • Type 1 or other specific causes of diabetes

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novo Nordisk Investigational Site Vestavia Alabama United States 35209
    2 Novo Nordisk Investigational Site Tucson Arizona United States 85719
    3 Novo Nordisk Investigational Site Carlisle Arkansas United States 72024
    4 Novo Nordisk Investigational Site Jonesboro Arkansas United States 72401
    5 Novo Nordisk Investigational Site Alhambra California United States 91801
    6 Novo Nordisk Investigational Site Mission Viejo California United States 92691
    7 Novo Nordisk Investigational Site Walnut Creek California United States 94598
    8 Novo Nordisk Investigational Site Trumbull Connecticut United States 06611
    9 Novo Nordisk Investigational Site Jacksonville Florida United States 32216
    10 Novo Nordisk Investigational Site Melbourne Florida United States 32901
    11 Novo Nordisk Investigational Site Miami Florida United States 33156
    12 Novo Nordisk Investigational Site Ocala Florida United States 34471
    13 Novo Nordisk Investigational Site Pembroke Pines Florida United States 33024
    14 Novo Nordisk Investigational Site St. Petersburg Florida United States 33702
    15 Novo Nordisk Investigational Site Titusville Florida United States 32796
    16 Novo Nordisk Investigational Site West Palm Beach Florida United States 33401
    17 Novo Nordisk Investigational Site Chicago Illinois United States 60607
    18 Novo Nordisk Investigational Site Springfield Illinois United States 62711
    19 Novo Nordisk Investigational Site Worcester Massachusetts United States 01605
    20 Novo Nordisk Investigational Site Duluth Minnesota United States 55805
    21 Novo Nordisk Investigational Site St. Louis Missouri United States 63117
    22 Novo Nordisk Investigational Site St. Louis Missouri United States 63141
    23 Novo Nordisk Investigational Site North Plainfield New Jersey United States 07060
    24 Novo Nordisk Investigational Site Charlotte North Carolina United States 28277
    25 Novo Nordisk Investigational Site Durham North Carolina United States 27710
    26 Novo Nordisk Investigational Site Oklahoma City Oklahoma United States 73104
    27 Novo Nordisk Investigational Site Chattanooga Tennessee United States 37404
    28 Novo Nordisk Investigational Site Corpus Christi Texas United States 78404
    29 Novo Nordisk Investigational Site Dallas Texas United States 75230
    30 Novo Nordisk Investigational Site Dallas Texas United States 75246
    31 Novo Nordisk Investigational Site San Antonio Texas United States 78209
    32 Novo Nordisk Investigational Site San Antonio Texas United States 78229
    33 Novo Nordisk Investigational Site Salt Lake City Utah United States 84132
    34 Novo Nordisk Investigational Site Richmond Virginia United States 23294
    35 Novo Nordisk Investigational Site Edmonds Washington United States 98026-7610
    36 Novo Nordisk Investigational Site Edmonds Washington United States 98026
    37 Novo Nordisk Investigational Site Renton Washington United States 98057
    38 Novo Nordisk Investigational Site Tacoma Washington United States 98405
    39 Novo Nordisk Investigational Site Charleston West Virginia United States 25301

    Sponsors and Collaborators

    • Novo Nordisk A/S

    Investigators

    • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Novo Nordisk A/S
    ClinicalTrials.gov Identifier:
    NCT01511198
    Other Study ID Numbers:
    • NN2211-2072
    First Posted:
    Jan 18, 2012
    Last Update Posted:
    Jan 26, 2017
    Last Verified:
    Jan 1, 2017
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Metformin
    Liraglutide

    Study Results

    No Results Posted as of Jan 26, 2017