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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01923181
• Other study ID #: NN9924-3790
• Secondary ID: 2012-004994-16U1
• Status: Completed
• Phase: Phase 2
• Start date: December 2, 2013
• Est. completion date: December 11, 2014

Study information

• Verified date: January 2021
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 632
• Est. completion date: December 11, 2014
• Est. primary completion date: December 11, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• semaglutide
Once-daily oral administration as tablets.
• semaglutide
Once-weekly,injected s.c./subcutaneously (under the skin) using a pen
• oral placebo
Once-daily oral administration as tablets.

Locations

Country	Name	City	State
Austria	Novo Nordisk Investigational Site	Graz
Austria	Novo Nordisk Investigational Site	Saint Stefan
Austria	Novo Nordisk Investigational Site	Wien
Austria	Novo Nordisk Investigational Site	Wien
Austria	Novo Nordisk Investigational Site	Wien
Austria	Novo Nordisk Investigational Site	Wien
Bulgaria	Novo Nordisk Investigational Site	Sofia
Canada	Novo Nordisk Investigational Site	Bathurst	New Brunswick
Canada	Novo Nordisk Investigational Site	Burlington	Ontario
Canada	Novo Nordisk Investigational Site	Moncton	New Brunswick
Canada	Novo Nordisk Investigational Site	Pointe-Claire	Quebec
Canada	Novo Nordisk Investigational Site	Stayner	Ontario
Canada	Novo Nordisk Investigational Site	Toronto	Ontario
Denmark	Novo Nordisk Investigational Site	Aalborg
Denmark	Novo Nordisk Investigational Site	Århus C
Denmark	Novo Nordisk Investigational Site	Esbjerg
Denmark	Novo Nordisk Investigational Site	Hellerup
Denmark	Novo Nordisk Investigational Site	Hillerød
Denmark	Novo Nordisk Investigational Site	Svendborg
Germany	Novo Nordisk Investigational Site	Elsterwerda
Germany	Novo Nordisk Investigational Site	Falkensee
Germany	Novo Nordisk Investigational Site	Friedrichsthal
Germany	Novo Nordisk Investigational Site	Hamburg
Germany	Novo Nordisk Investigational Site	Münster
Germany	Novo Nordisk Investigational Site	Saint Ingbert-Oberwürzbach
Germany	Novo Nordisk Investigational Site	Speyer
Israel	Novo Nordisk Investigational Site	Beer Sheva
Israel	Novo Nordisk Investigational Site	Haifa
Israel	Novo Nordisk Investigational Site	Herzliya
Israel	Novo Nordisk Investigational Site	Holon
Israel	Novo Nordisk Investigational Site	Jerusalem
Israel	Novo Nordisk Investigational Site	Kfar Saba
Israel	Novo Nordisk Investigational Site	Rishon Le Zion
Italy	Novo Nordisk Investigational Site	Milano
Italy	Novo Nordisk Investigational Site	Padova
Italy	Novo Nordisk Investigational Site	Roma
Italy	Novo Nordisk Investigational Site	Roma
Italy	Novo Nordisk Investigational Site	Verona
Malaysia	Novo Nordisk Investigational Site	Ipoh
Malaysia	Novo Nordisk Investigational Site	Kota Bharu
Malaysia	Novo Nordisk Investigational Site	Penang
Malaysia	Novo Nordisk Investigational Site	Seri Manjung
Serbia	Novo Nordisk Investigational Site	Belgrade
South Africa	Novo Nordisk Investigational Site	Johannesburg	Gauteng
South Africa	Novo Nordisk Investigational Site	Johannesburg	Gauteng
South Africa	Novo Nordisk Investigational Site	Port Elizabeth	Eastern Cape
Spain	Novo Nordisk Investigational Site	Almería
Spain	Novo Nordisk Investigational Site	Sabadell
Spain	Novo Nordisk Investigational Site	Sevilla
Spain	Novo Nordisk Investigational Site	Sevilla
Spain	Novo Nordisk Investigational Site	Valencia
Sweden	Novo Nordisk Investigational Site	Karlstad
Sweden	Novo Nordisk Investigational Site	Linköping
Sweden	Novo Nordisk Investigational Site	Örebro
Sweden	Novo Nordisk Investigational Site	Oskarshamn
United Kingdom	Novo Nordisk Investigational Site	Belfast
United Kingdom	Novo Nordisk Investigational Site	Bexhill-on-Sea
United Kingdom	Novo Nordisk Investigational Site	Chester
United Kingdom	Novo Nordisk Investigational Site	Chesterfield, Derbyshire
United Kingdom	Novo Nordisk Investigational Site	Crewe
United Kingdom	Novo Nordisk Investigational Site	Hinckley
United Kingdom	Novo Nordisk Investigational Site	Leicester
United Kingdom	Novo Nordisk Investigational Site	London
United States	Novo Nordisk Investigational Site	Addison	Illinois
United States	Novo Nordisk Investigational Site	Asheville	North Carolina
United States	Novo Nordisk Investigational Site	Athens	Georgia
United States	Novo Nordisk Investigational Site	Chicago	Illinois
United States	Novo Nordisk Investigational Site	Chula Vista	California
United States	Novo Nordisk Investigational Site	Colorado Springs	Colorado
United States	Novo Nordisk Investigational Site	Conyers	Georgia
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Denver	Colorado
United States	Novo Nordisk Investigational Site	Fargo	North Dakota
United States	Novo Nordisk Investigational Site	Humboldt	Tennessee
United States	Novo Nordisk Investigational Site	Jacksonville	Florida
United States	Novo Nordisk Investigational Site	Jersey Shore	Pennsylvania
United States	Novo Nordisk Investigational Site	Las Vegas	Nevada
United States	Novo Nordisk Investigational Site	Las Vegas	Nevada
United States	Novo Nordisk Investigational Site	Long Beach	California
United States	Novo Nordisk Investigational Site	Miami	Florida
United States	Novo Nordisk Investigational Site	Moncks Corner	South Carolina
United States	Novo Nordisk Investigational Site	New York	New York
United States	Novo Nordisk Investigational Site	New York	New York
United States	Novo Nordisk Investigational Site	Newport News	Virginia
United States	Novo Nordisk Investigational Site	Norman	Oklahoma
United States	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania
United States	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania
United States	Novo Nordisk Investigational Site	Plantation	Florida
United States	Novo Nordisk Investigational Site	Poway	California
United States	Novo Nordisk Investigational Site	Raleigh	North Carolina
United States	Novo Nordisk Investigational Site	Rochester	New York
United States	Novo Nordisk Investigational Site	Rockville	Maryland
United States	Novo Nordisk Investigational Site	Salisbury	North Carolina
United States	Novo Nordisk Investigational Site	San Antonio	Texas
United States	Novo Nordisk Investigational Site	Santa Ana	California
United States	Novo Nordisk Investigational Site	South Miami	Florida
United States	Novo Nordisk Investigational Site	Spring Hill	Tennessee
United States	Novo Nordisk Investigational Site	Spring Valley	California
United States	Novo Nordisk Investigational Site	Sugar Land	Texas
United States	Novo Nordisk Investigational Site	Tucson	Arizona
United States	Novo Nordisk Investigational Site	Walnut Creek	California
United States	Novo Nordisk Investigational Site	Wenatchee	Washington
United States	Novo Nordisk Investigational Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Austria,  Bulgaria,  Canada,  Denmark,  Germany,  Israel,  Italy,  Malaysia,  Serbia,  South Africa,  Spain,  Sweden,  United Kingdom, 

References & Publications (1)

Davies M, Pieber TR, Hartoft-Nielsen ML, Hansen OKH, Jabbour S, Rosenstock J. Effect of Oral Semaglutide Compared With Placebo and Subcutaneous Semaglutide on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA. 2017 Oct 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c (Glycosylated Haemoglobin)	Change from baseline (week 0) in HbA1c was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.	Week 0, week 26
Secondary	Subjects Who Achieve (Yes/no) HbA1c Below 7 Percent (53 mmol/Mol)	Participants who achieved HbA1c <7.0%, was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.	After 26 weeks of treatment
Secondary	Change in Body Weight	Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.	Week 0, Week 26
Secondary	Change in Waist Circumference	Change from baseline (week 0) in waist circumference was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.	Week 0, week 26
Secondary	Change in Body Mass Index (BMI)	Change from baseline (week 0) in body mass index (BMI) was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.	Week 0, week 26
Secondary	Number of Treatment Emergent Adverse Events (TEAEs) Recorded	TEAEs were recorded during weeks 0-31 (26 weeks treatment period+5 weeks follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.	Weeks 0-31
Secondary	Number of Confirmed Hypoglycaemic Episodes Recorded	Treatment-emergent confirmed hypoglycaemic episodes were recorded during weeks 0-31 (26 weeks treatment period + 5 weeks follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Confirmed hypoglycaemic episode is an episode that is severe according to the American Diabetes Association (ADA) classification or plasma glucose value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia.	Weeks 0-31

External Links

•   Clinical Trials at Novo Nordisk