Clinical trial NCT01923181: Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes
Official title: Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-08-15
Enrollment: 632
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change in HbA1c (Glycosylated Haemoglobin)
timeFrame: Week 0, week 26
Secondary outcomes:
measure: Subjects Who Achieve (Yes/no) HbA1c Below 7 Percent (53 mmol/Mol)
timeFrame: After 26 weeks of treatment
measure: Change in Body Weight
timeFrame: Week 0, Week 26
measure: Change in Waist Circumference
timeFrame: Week 0, week 26
measure: Change in Body Mass Index (BMI)
timeFrame: Week 0, week 26
measure: Number of Treatment Emergent Adverse Events (TEAEs) Recorded
timeFrame: Weeks 0-31
measure: Number of Confirmed Hypoglycaemic Episodes Recorded
timeFrame: Weeks 0-31
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Chula Vista
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Long Beach
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Poway
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Santa Ana
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Spring Valley
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Denver
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Plantation
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: South Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Athens
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Conyers
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Addison
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Wichita
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
city: Rockville
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Las Vegas
country: United States
facility: Novo Nordisk Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Novo Nordisk Investigational Site
state: Nevada
city: New York
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: New York
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Rochester
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Asheville
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Fargo
country: United States
facility: Novo Nordisk Investigational Site
state: North Dakota
city: Norman
country: United States
facility: Novo Nordisk Investigational Site
state: Oklahoma
city: Jersey Shore
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Moncks Corner
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Humboldt
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Spring Hill
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Newport News
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Wenatchee
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Graz
country: Austria
facility: Novo Nordisk Investigational Site
city: Saint Stefan
country: Austria
facility: Novo Nordisk Investigational Site
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Sofia
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Bathurst
country: Canada
facility: Novo Nordisk Investigational Site
state: New Brunswick
city: Moncton
country: Canada
facility: Novo Nordisk Investigational Site
state: New Brunswick
city: Burlington
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Stayner
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Pointe-Claire
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Aalborg
country: Denmark
facility: Novo Nordisk Investigational Site
city: Esbjerg
country: Denmark
facility: Novo Nordisk Investigational Site
city: Hellerup
country: Denmark
facility: Novo Nordisk Investigational Site
city: Hillerød
country: Denmark
facility: Novo Nordisk Investigational Site
city: Svendborg
country: Denmark
facility: Novo Nordisk Investigational Site
city: Århus C
country: Denmark
facility: Novo Nordisk Investigational Site
city: Elsterwerda
country: Germany
facility: Novo Nordisk Investigational Site
city: Falkensee
country: Germany
facility: Novo Nordisk Investigational Site
city: Friedrichsthal
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Münster
country: Germany
facility: Novo Nordisk Investigational Site
city: Saint Ingbert-Oberwürzbach
country: Germany
facility: Novo Nordisk Investigational Site
city: Speyer
country: Germany
facility: Novo Nordisk Investigational Site
city: Beer Sheva
country: Israel
facility: Novo Nordisk Investigational Site
city: Haifa
country: Israel
facility: Novo Nordisk Investigational Site
city: Herzliya
country: Israel
facility: Novo Nordisk Investigational Site
city: Holon
country: Israel
facility: Novo Nordisk Investigational Site
city: Jerusalem
country: Israel
facility: Novo Nordisk Investigational Site
city: Kfar Saba
country: Israel
facility: Novo Nordisk Investigational Site
city: Rishon Le Zion
country: Israel
facility: Novo Nordisk Investigational Site
city: Milano
country: Italy
facility: Novo Nordisk Investigational Site
city: Padova
country: Italy
facility: Novo Nordisk Investigational Site
city: Roma
country: Italy
facility: Novo Nordisk Investigational Site
city: Roma
country: Italy
facility: Novo Nordisk Investigational Site
city: Verona
country: Italy
facility: Novo Nordisk Investigational Site
city: Ipoh
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Kota Bharu
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Penang
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Seri Manjung
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Belgrade
country: Serbia
facility: Novo Nordisk Investigational Site
city: Port Elizabeth
country: South Africa
facility: Novo Nordisk Investigational Site
state: Eastern Cape
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Almería
country: Spain
facility: Novo Nordisk Investigational Site
city: Sabadell
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Valencia
country: Spain
facility: Novo Nordisk Investigational Site
city: Karlstad
country: Sweden
facility: Novo Nordisk Investigational Site
city: Linköping
country: Sweden
facility: Novo Nordisk Investigational Site
city: Oskarshamn
country: Sweden
facility: Novo Nordisk Investigational Site
city: Örebro
country: Sweden
facility: Novo Nordisk Investigational Site
city: Belfast
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bexhill-on-Sea
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Chesterfield, Derbyshire
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Chester
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Crewe
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Hinckley
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Leicester
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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 17;318(15):1460-1470. doi: 10.1001/jama.2017.14752.