A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily in Japanese Subjects With Type 2 Diabetes

NCT ID: NCT02254291

Last Updated: 2018-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 308 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-02
• Study Completion Date: 2015-11-11

Brief Summary

This trial is conducted in Japan. The purpose is to compare the safety of once-weekly dosing of semaglutide (0.5 and 1.0 mg) versus sitagliptin (100 mg) once daily, both as monotherapy during 30 weeks of treatment in Japanese subjects with type 2 diabetes.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Semaglutide 0.5 mg

Group Type: EXPERIMENTAL

semaglutide

Intervention Type: DRUG

Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg (4 weeks). Total duration of treatment is 30 weeks. Administered subcutaneously (s.c. under the skin).

Semaglutide 1.0 mg

Group Type: EXPERIMENTAL

semaglutide

Intervention Type: DRUG

Once weekly doses of 1.0 mg semaglutide after an initial dose escalation step of 0.25 mg (4 weeks) followed by 0.5 mg for 4 weeks. Total duration of treatment is 30 weeks. Administered subcutaneously (s.c. under the skin).

Sitagliptin 100 mg

Group Type: ACTIVE_COMPARATOR

sitagliptin

Intervention Type: DRUG

Daily doses of 100 mg sitagliptin. Total duration of treatment is 30 weeks. Administered as oral tablets.

Interventions

semaglutide

Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg (4 weeks). Total duration of treatment is 30 weeks. Administered subcutaneously (s.c. under the skin).

Intervention Type: DRUG

semaglutide

Once weekly doses of 1.0 mg semaglutide after an initial dose escalation step of 0.25 mg (4 weeks) followed by 0.5 mg for 4 weeks. Total duration of treatment is 30 weeks. Administered subcutaneously (s.c. under the skin).

Intervention Type: DRUG

sitagliptin

Daily doses of 100 mg sitagliptin. Total duration of treatment is 30 weeks. Administered as oral tablets.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female, age 20 years or older at the time of signing informed consent
• Glycated hemoglobin (HbA1c) between 6.5% and 9.5% (48-80 mmol/mol) (both inclusive) for subjects treated with oral antidiabetic drug (OAD) monotherapy and between 7.0% and 10.5% (53-91 mmol/mol) (both inclusive) for subjects treated with diet and exercise therapy at screening
• Japanese subjects diagnosed with type 2 diabetes who are: a) on stable OAD monotherapy at a half-maximum dose or below according to the approved Japanese labelling in addition to diet and exercise therapy for at least 30 days prior to screening (week -8) (For metformin only: the maximum dose of 750 mg/day is allowed except for METGLUCO®. For METGLUCO®, the allowable half-max dose of 1125 mg/day must be applied.). 'Stable' is defined as unchanged medication and unchanged dose, or b) on stable diet and exercise therapy for at least 30 days prior to screening (week -2)

Exclusion Criteria

• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (e.g. abstinence, diaphragm, condom [by the partner], intrauterine device, sponge, spermicide or oral contraceptives) throughout the trial including the 5-week follow-up period
• Treatment with once-weekly glucagon-like peptide-1 (GLP-1) receptor agonists within 90 days prior to screening
• Treatment with any glucose lowering agent(s) (except for pre-trial OAD for subject treated with OAD monotherapy) in a period of 60 days prior to screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with inter-current illness
• Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
• History of chronic or idiopathic acute pancreatitis
• Screening calcitonin value of 50 ng/L (pg/mL) or greater
• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
• Impaired renal function defined as estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version)
• Acute coronary or cerebrovascular event within 90 days before randomisation
• Heart failure, New York Heart Association (NYHA) class IV

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry GCR, 1452

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Asahikawa-shi, Hokkaido, , Japan

Novo Nordisk Investigational Site

Chitose, Hokkaido, , Japan

Novo Nordisk Investigational Site

Chuo-ku Tokyo, , Japan

Novo Nordisk Investigational Site

Chuo-ku Tokyo, , Japan

Novo Nordisk Investigational Site

Chuo-ku, Tokyo, , Japan

Novo Nordisk Investigational Site

Ebina-shi, , Japan

Novo Nordisk Investigational Site

Izumisano, , Japan

Novo Nordisk Investigational Site

Kashiwara-shi, Osaka, , Japan

Novo Nordisk Investigational Site

Katsushika-ku, Tokyo, , Japan

Novo Nordisk Investigational Site

Kumamoto-shi,Kumamoto, , Japan

Novo Nordisk Investigational Site

Naka-shi, Ibaraki, , Japan

Novo Nordisk Investigational Site

Nishinomiya-shi, Hygo, , Japan

Novo Nordisk Investigational Site

Osaka-shi, Osaka, , Japan

Novo Nordisk Investigational Site

Ota-ku, Tokyo, , Japan

Novo Nordisk Investigational Site

Ota-ku, Tokyo, , Japan

Novo Nordisk Investigational Site

Ōita, , Japan

Novo Nordisk Investigational Site

Sapporo-shi, Hokkaido, , Japan

Novo Nordisk Investigational Site

Sapporo-shi, Hokkaido, , Japan

Novo Nordisk Investigational Site

Shimotsuke-shi, Tochigi, , Japan

Novo Nordisk Investigational Site

Shinjuku-ku, Tokyo, , Japan

Novo Nordisk Investigational Site

Suita-shi, Osaka, , Japan

Novo Nordisk Investigational Site

Takatsuki-shi, Osaka, , Japan

Novo Nordisk Investigational Site

Tokyo, , Japan

Novo Nordisk Investigational Site

Yokohama, , Japan

Novo Nordisk Investigational Site

Yokohama, Kanagawa, , Japan

Countries

Japan

References

Seino Y, Terauchi Y, Osonoi T, Yabe D, Abe N, Nishida T, Zacho J, Kaneko S. Safety and efficacy of semaglutide once weekly vs sitagliptin once daily, both as monotherapy in Japanese people with type 2 diabetes. Diabetes Obes Metab. 2018 Feb;20(2):378-388. doi: 10.1111/dom.13082. Epub 2017 Oct 5.

Reference Type: RESULT

PMID: 28786547 (View on PubMed)

Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.

Reference Type: DERIVED

PMID: 32998732 (View on PubMed)

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

U1111-1140-5334

Identifier Type: OTHER

Identifier Source: secondary_id

JapicCTI-142663

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN9535-4092

Identifier Type: -

Identifier Source: org_study_id