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Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01923181
First Posted: August 15, 2013
Last Update Posted: March 31, 2017
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.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This trial is conducted globally. The aim of the trial is to examine the dose range, escalation and efficacy of oral semaglutide in subjects with type 2 diabetes.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: semaglutide Drug: oral placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in HbA1c (Glycosylated haemoglobin)) [ Time Frame: Week 0, Week 26 ]

Secondary Outcome Measures:
  • Subjects who achieve (yes/no) HbA1c below 7 percent (53 mmol/mol) [ Time Frame: After 26 weeks of treatment ]
  • Change in body weight [ Time Frame: Week 0, Week 26 ]
  • Change in waist circumference [ Time Frame: week 0, week 26 ]
  • Change in body mass index (BMI) [ Time Frame: week 0, week 26 ]
  • Number of treatment emergent adverse events (TEAEs) recorded [ Time Frame: Weeks 0-31 ]
  • Number of confirmed hypoglycaemic episodes recorded [ Time Frame: Weeks 0-31 ]

Enrollment: 632
Actual Study Start Date: December 2, 2013
Study Completion Date: December 11, 2014
Primary Completion Date: December 11, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1:Semaglutide tablets : 2.5 mg
2.5 mg for 26 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Drug: semaglutide
Once-daily oral administration as tablets.
Experimental: 2:Semaglutide tablets: 2.5 mg/5 mg
2.5 mg for 4 weeks, then 5.0 mg for 22 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Drug: semaglutide
Once-daily oral administration as tablets.
Experimental: 3:Semaglutide tablets: 5.0 mg/10 mg
5.0 mg for 4 weeks, then 10 mg for 22 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Drug: semaglutide
Once-daily oral administration as tablets.
Experimental: 4:Semaglutide tablets:5.0 mg/10 mg/20 mg
5.0 mg for 4 weeks, then 10 mg for 4 weeks, then 20 mg for 18 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Drug: semaglutide
Once-daily oral administration as tablets.
Experimental: 5:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg

5.0 mg for 4 weeks, then 10 mg for 4 weeks, then 20 mg for 4 weeks, then 40 mg for 14 weeks.

All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.

Drug: semaglutide
Once-daily oral administration as tablets.
Experimental: 6:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg
5.0 mg for 8 weeks, then 10 mg for 8 weeks, then 20 mg for 8 weeks, then 40 mg for 2 weeks All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Drug: semaglutide
Once-daily oral administration as tablets.
Experimental: 7:Semaglutide tablets: 5.0 mg/10 mg/20 mg/40 mg

5.0 mg for 2 weeks, then 10 mg for 2 weeks, then 20 mg for 2 weeks, then 40 mg for 20 weeks.

All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.

Drug: semaglutide
Once-daily oral administration as tablets.
Placebo Comparator: 8:Placebo tablets
All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Drug: oral placebo
Once-daily oral administration as tablets.
Active Comparator: 9:Semaglutide injections :0.25 mg/0.50 mg/1.0 mg
0.25 mg for 4 weeks, then 0.50 mg for 4 weeks, then 1.0 mg for 18 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Drug: semaglutide
Once-weekly,injected s.c./subcutaneously (under the skin) using a pen

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • BMI above or equal to 25 and below or equal to 40 kg/m^2
  • Subjects diagnosed with T2D (Type 2 diabetes) treated with diet and exercise and/or who have been on a stable dose of metformin for at least 30 days prior to screening
  • HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive)

Exclusion Criteria:

  • Subjects on selected oral medication with a narrow therapeutic window, such as warfarin, digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline and anticonvulsants
  • History of chronic pancreatitis or idiopathic acute pancreatitis
  • Chronic malabsorption, regardless of aetiology
  • History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
  • Treatment with glucose lowering agent(s) other than metformin as stated in the inclusion criteria in a period of 90 days before the screening visit
  Contacts and Locations
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): NCT01923181


  Hide Study Locations
Locations
United States, Arizona
Novo Nordisk Investigational Site
Tucson, Arizona, United States, 85712
United States, California
Novo Nordisk Investigational Site
Chula Vista, California, United States, 91911
Novo Nordisk Investigational Site
Long Beach, California, United States, 90806
Novo Nordisk Investigational Site
Poway, California, United States, 92064
Novo Nordisk Investigational Site
Santa Ana, California, United States, 92705
Novo Nordisk Investigational Site
Spring Valley, California, United States, 91978
Novo Nordisk Investigational Site
Walnut Creek, California, United States, 94598
United States, Colorado
Novo Nordisk Investigational Site
Colorado Springs, Colorado, United States, 80904
Novo Nordisk Investigational Site
Denver, Colorado, United States, 80220
United States, Florida
Novo Nordisk Investigational Site
Jacksonville, Florida, United States, 32207
Novo Nordisk Investigational Site
Miami, Florida, United States, 33014
Novo Nordisk Investigational Site
Plantation, Florida, United States, 33324
Novo Nordisk Investigational Site
South Miami, Florida, United States, 33143
United States, Georgia
Novo Nordisk Investigational Site
Athens, Georgia, United States, 30606
Novo Nordisk Investigational Site
Conyers, Georgia, United States, 30094-5965
United States, Illinois
Novo Nordisk Investigational Site
Addison, Illinois, United States, 60101
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60634
United States, Kansas
Novo Nordisk Investigational Site
Wichita, Kansas, United States, 67203
United States, Maryland
Novo Nordisk Investigational Site
Rockville, Maryland, United States, 20852
United States, Nevada
Novo Nordisk Investigational Site
Las Vegas, Nevada, United States, 89103
Novo Nordisk Investigational Site
Las Vegas, Nevada, United States, 89109
United States, New York
Novo Nordisk Investigational Site
New York, New York, United States, 10001
Novo Nordisk Investigational Site
New York, New York, United States, 10032
Novo Nordisk Investigational Site
Rochester, New York, United States, 14609
United States, North Carolina
Novo Nordisk Investigational Site
Asheville, North Carolina, United States, 28801
Novo Nordisk Investigational Site
Raleigh, North Carolina, United States, 27609
Novo Nordisk Investigational Site
Salisbury, North Carolina, United States, 28144
United States, North Dakota
Novo Nordisk Investigational Site
Fargo, North Dakota, United States, 58103
United States, Oklahoma
Novo Nordisk Investigational Site
Norman, Oklahoma, United States, 73069
United States, Pennsylvania
Novo Nordisk Investigational Site
Jersey Shore, Pennsylvania, United States, 17740
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19140
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19147
United States, South Carolina
Novo Nordisk Investigational Site
Moncks Corner, South Carolina, United States, 29461
United States, Tennessee
Novo Nordisk Investigational Site
Humboldt, Tennessee, United States, 38343
Novo Nordisk Investigational Site
Spring Hill, Tennessee, United States, 37174
United States, Texas
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75230
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78209
Novo Nordisk Investigational Site
Sugar Land, Texas, United States, 77478
United States, Virginia
Novo Nordisk Investigational Site
Newport News, Virginia, United States, 23606
United States, Washington
Novo Nordisk Investigational Site
Wenatchee, Washington, United States, 98801-2028
Austria
Novo Nordisk Investigational Site
Graz, Austria, 8036
Novo Nordisk Investigational Site
St. Stefan, Austria, 8511
Novo Nordisk Investigational Site
Wien, Austria, 1010
Novo Nordisk Investigational Site
Wien, Austria, 1030
Novo Nordisk Investigational Site
Wien, Austria, 1060
Novo Nordisk Investigational Site
Wien, Austria, 1130
Bulgaria
Novo Nordisk Investigational Site
Sofia, Bulgaria, 1431
Canada, New Brunswick
Novo Nordisk Investigational Site
Bathurst, New Brunswick, Canada, E2A 4Z9
Novo Nordisk Investigational Site
Moncton, New Brunswick, Canada, E1G 1A7
Canada, Ontario
Novo Nordisk Investigational Site
Burlington, Ontario, Canada, L7R 1E2
Novo Nordisk Investigational Site
Stayner, Ontario, Canada, L0M 1S0
Novo Nordisk Investigational Site
Toronto, Ontario, Canada, M9W 4L6
Canada, Quebec
Novo Nordisk Investigational Site
Pointe-Claire, Quebec, Canada, H9R 3JI
Denmark
Novo Nordisk Investigational Site
Aalborg, Denmark, 9100
Novo Nordisk Investigational Site
Esbjerg, Denmark, 6700
Novo Nordisk Investigational Site
Hellerup, Denmark, 2900
Novo Nordisk Investigational Site
Hillerød, Denmark, 3400
Novo Nordisk Investigational Site
Svendborg, Denmark, 5700
Novo Nordisk Investigational Site
Århus C, Denmark, 8000
Germany
Novo Nordisk Investigational Site
Elsterwerda, Germany, 04910
Novo Nordisk Investigational Site
Falkensee, Germany, 14612
Novo Nordisk Investigational Site
Friedrichsthal, Germany, 66299
Novo Nordisk Investigational Site
Hamburg, Germany, 22607
Novo Nordisk Investigational Site
Münster, Germany, 48145
Novo Nordisk Investigational Site
Speyer, Germany, 67346
Novo Nordisk Investigational Site
St. Ingbert, Germany, 66386
Israel
Novo Nordisk Investigational Site
Beer Sheva, Israel, 84101
Novo Nordisk Investigational Site
Haifa, Israel, 31096
Novo Nordisk Investigational Site
Herzliya, Israel, 46851
Novo Nordisk Investigational Site
Holon, Israel, 58100
Novo Nordisk Investigational Site
Jerusalem, Israel, 91120
Novo Nordisk Investigational Site
Kfar Saba, Israel, 44281
Novo Nordisk Investigational Site
Rishon Le Zion, Israel, 75650
Italy
Novo Nordisk Investigational Site
Milano, Italy, 20132
Novo Nordisk Investigational Site
Padova, Italy, 35128
Novo Nordisk Investigational Site
Roma, Italy, 00133
Novo Nordisk Investigational Site
Roma, Italy, 00161
Novo Nordisk Investigational Site
Verona, Italy, 37126
Malaysia
Novo Nordisk Investigational Site
Ipoh, Malaysia, 30450
Novo Nordisk Investigational Site
Kota Bharu, Malaysia, 15586
Novo Nordisk Investigational Site
Penang, Malaysia, 10450
Novo Nordisk Investigational Site
Seri Manjung, Malaysia, 32040
Serbia
Novo Nordisk Investigational Site
Belgrade, Serbia, 11000
South Africa
Novo Nordisk Investigational Site
Port Elizabeth, Eastern Cape, South Africa, 6045
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 1829
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 2090
Spain
Novo Nordisk Investigational Site
Almería, Spain, 04001
Novo Nordisk Investigational Site
Sabadell, Spain, 08208
Novo Nordisk Investigational Site
Sevilla, Spain, 41003
Novo Nordisk Investigational Site
Sevilla, Spain, 41010
Novo Nordisk Investigational Site
Valencia, Spain, 46026
Sweden
Novo Nordisk Investigational Site
Karlstad, Sweden, 651 85
Novo Nordisk Investigational Site
Linköping, Sweden, 582 16
Novo Nordisk Investigational Site
Oskarshamn, Sweden, 572 28
Novo Nordisk Investigational Site
Örebro, Sweden, 701 85
United Kingdom
Novo Nordisk Investigational Site
Belfast, United Kingdom, BT16 1RH
Novo Nordisk Investigational Site
Bexhill-on-Sea, United Kingdom, TN39 4SP
Novo Nordisk Investigational Site
Chesterfield, Derbyshire, United Kingdom, S40 4AA
Novo Nordisk Investigational Site
Chester, United Kingdom, CH2 1UL
Novo Nordisk Investigational Site
Crewe, United Kingdom, CW5 5NX
Novo Nordisk Investigational Site
Hinckley, United Kingdom, LE10 2SE
Novo Nordisk Investigational Site
Leicester, United Kingdom, LE5 4PW
Novo Nordisk Investigational Site
London, United Kingdom, W6 7HY
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01923181     History of Changes
Other Study ID Numbers: NN9924-3790
2012-004994-16 ( EudraCT Number )
U1111-1136-4716 ( Other Identifier: WHO )
First Submitted: August 13, 2013
First Posted: August 15, 2013
Last Update Posted: March 31, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases