A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus

NCT01468181 | Completed Phase 3 Results

• 2 other identifiers: 13991H9X-JE-GBDQ
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 14

Brief Summary

This was a 52-week, multicenter, non-randomized, open-label, Phase 3 long-term safety study in participants with type 2 diabetes mellitus who have inadequate glycemic control with monotherapy of oral antihyperglycemic medication (OAM).

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus; Oral antihyperglycemic medications; Long-Term Safety; GLP 1; Glucagon like peptide 1

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

  A TEAE was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

  Baseline through 52 Weeks

• Percentage of Participants With Hypoglycemic Episodes

  The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least 1 hypoglycemic episode over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

  Baseline through 52 Weeks

Secondary Outcomes (6)

• Change From Baseline in Glycosylated Hemoglobin (HbA1c)

  Baseline, up to 26 Weeks and up to 52 Weeks

• Percentage of Participants Who Achieve HbA1c ≤6.5% or <7%

  26 weeks and 52 weeks

• Change From Baseline in Fasting Blood Glucose (FBG)

  Baseline, up to 26 weeks and up to 52 weeks

• Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)

  Baseline, up to 26 weeks and up to 52 weeks

• Change From Baseline in Body Weight

  Baseline, up to 26 weeks and up to 52 weeks

Study Arms (5)

LY2189265 + Sulfonylureas (SU)

EXPERIMENTAL

LY2189265: 0.75 milligrams (mg) administered subcutaneously (SC), once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.

Drug: LY2189265; Drug: Sulfonylureas (SU)

LY2189265 + Biguanides (BG)

EXPERIMENTAL

LY2189265: 0.75 mg administered SC, once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.

Drug: LY2189265; Drug: Biguanides (BG)

LY2189265 + alpha-glucosidase inhibitor (a-GI)

EXPERIMENTAL

LY2189265: 0.75 mg administered SC, once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.

Drug: LY2189265; Drug: alpha-glucosidase inhibitor (a-GI)

LY2189265 + Thiazolidinedione (TZD)

EXPERIMENTAL

LY2189265: 0.75 mg administered SC, once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.

Drug: LY2189265; Drug: Thiazolidinedione (TZD)

LY2189265 + Glinides

EXPERIMENTAL

LY2189265: 0.75 mg administered SC, once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.

Drug: LY2189265; Drug: Glinides

Interventions

LY2189265 DRUG

Also known as: Dulaglutide

LY2189265 + Biguanides (BG); LY2189265 + Glinides; LY2189265 + Sulfonylureas (SU); LY2189265 + Thiazolidinedione (TZD); LY2189265 + alpha-glucosidase inhibitor (a-GI)

Sulfonylureas (SU) DRUG

SU is a pre-study prescribed dose and is not being provided as part of the trial.

LY2189265 + Sulfonylureas (SU)

Biguanides (BG) DRUG

Biguanides is a pre-study prescribed dose and is not being provided as part of the trial.

LY2189265 + Biguanides (BG)

alpha-glucosidase inhibitor (a-GI) DRUG

a-GI is a pre-study prescribed dose and is not being provided as part of the trial.

LY2189265 + alpha-glucosidase inhibitor (a-GI)

Thiazolidinedione (TZD) DRUG

TZD is a pre-study prescribed dose and is not being provided as part of the trial.

LY2189265 + Thiazolidinedione (TZD)

Glinides DRUG

Glinides is a pre-study prescribed dose and is not being provided as part of the trial.

LY2189265 + Glinides

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who have had a diagnosis of type 2 diabetes mellitus before screening
• Participants who have been taking SU (Glibenclamide, Gliclazide, Glimepiride), BG, TZD, a-GI or glinides monotherapy for at least 3 months before screening and have been on a stable dose for at least 8 weeks before screening
• Participants must have a qualifying HbA1c value of 7.0% to 11.0% at screening
• Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m\^2)

You may not qualify if:

• Participants who have a diagnosis of type 1 diabetes
• Participants who have previously been treated with any other glucagon-like peptide-1 (GLP-1) analog within the 3 months before screening
• Participants who are currently taking insulin or have had previous insulin treatment within the 3 months before screening
• Participants who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis, or acute pancreatitis at screening, as determined by the investigator. Participants who have a serum amylase concentration ≥3 times the upper limit of the reference range and/or a serum lipase concentration ≥2 times the upper limit of the reference range, as determined by the central laboratory at screening
• Participants who have self or family history of medullary C-cell hyperplasia, focal hyperplasia, or medullary thyroid carcinoma (MTC)

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (14)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Aichi, 466-0815, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Chiba, 277-0825, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Hokkaido, 050-0073, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Hyōgo, 662-0971, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Ibaraki, 300-0053, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Kanagawa, 231-0023, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Kyoto, 615-8125, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Nagano, 390-1401, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Okayama, 700-8558, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Osaka, 560-0082, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Saitama, 3438577, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Tokyo, 1030002, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Toyama, 930-0859, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Wakayama, 644-0011, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide; Sulfonylurea Compounds; Biguanides; Glycoside Hydrolase Inhibitors; 2,4-thiazolidinedione

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Guanidines; Amidines; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT - 5, hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: November 9, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 29, 2015
• Results First Posted: December 16, 2014

Record last verified: 2015-01

Locations

JP (14)