A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus
This study is ongoing, but not recruiting participants.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01558271
First received: March 12, 2012
Last updated: May 15, 2013
Last verified: May 2013
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Purpose
The purpose of this trial is to examine the efficacy and safety of once-weekly LY2189265 in participants with type 2 diabetes mellitus who are not taking oral antidiabetic medication.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: LY2189265 Drug: Placebo Drug: Liraglutide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 3 Study of LY2189265 Monotherapy Compared to Placebo and Liraglutide in Patients With Type 2 Diabetes Mellitus |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Change from Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from Baseline in Glycosylated Hemoglobin (HbA1c) at 52 Weeks [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
- Percentage of Participants Who Achieve HbA1c <=6.5% or <7% [ Time Frame: 26 weeks and 52 weeks ] [ Designated as safety issue: No ]
- Change from Baseline in Fasting Blood Glucose (FBG) [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
- Change from Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
- Change from Baseline in Body Weight [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
- Change from Baseline in Insulin Sensitivity using Updated Homeostasis Model Assessment (HOMA 2) [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
- Change from Baseline in Beta-cell Function using Updated Homeostasis Model Assessment (HOMA 2) [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
- Percentage of Participants with Hypoglycemic Episodes [ Time Frame: Baseline through 26 Weeks and Baseline through 52 Weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 490 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: LY2189265
Once-weekly subcutaneous (SC) injection of 0.75 mg LY2189265 for 26 weeks, followed by 0.75 mg of SC LY2189265/week for an additional 26 weeks of open therapy.
|
Drug: LY2189265
0.75 mg administered by SC injection once weekly for up to 52 weeks
Other Name: Dulaglutide
|
|
Placebo Comparator: Placebo
Once-weekly SC injection of placebo for 26 weeks, followed by 0.75 mg of SC LY2189265/week for an additional 26 weeks of open therapy.
|
Drug: Placebo
Placebo administered by SC injection once weekly for 26 weeks
|
|
Active Comparator: Liraglutide
Once-daily SC injection of Liraglutide for 26 weeks, followed by once-daily SC injection of Liraglutide for an additional 26 weeks of open therapy.
|
Drug: Liraglutide
Liraglutide is open-label comparator in this trial. Once-daily SC injection of 0.3 mg for the first week followed by 0.6 mg for the second week, and then, 0.9 mg during the remaining treatment period.
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participants who have had a diagnosis of type 2 diabetes mellitus before screening
- Participants who have been Oral Antihyperglycemic Medication (OAM)-naïve (diet and exercise only) or been taking OAM monotherapy except for thiazolidinedione (TZD) and are willing to discontinue this medication. Participants taking OAM monotherapy must complete 8-week washout period prior to randomization.
- Participants who are OAM naïve with screening glycosylated hemoglobin (HbA1c) value of 7.0% to 10.0% and randomization HbA1c value of 7.0% to 10.0%, or who are taking OAM monotherapy with screening HbA1c value of 6.5% to 9.0% and randomization HbA1c value of 7.0% to 10.0%.
- Participants who have a body mass index (BMI) of 18.5kg/m^2 to 35.0kg/m^2.
Exclusion Criteria:
- 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
- Participants who have been receiving more than half of the maximum dose of sulfonylureas at screening.
- Participants who have been currently taking insulin or TZD, or have had previous insulin or TZD treatment within 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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558271
Locations
| Japan | |
| 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. | |
| Fukuoka, Japan, 819-0168 | |
| 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, Japan, 060-8604 | |
| 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. | |
| Hyogo, Japan, 663-8501 | |
| 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, Japan, 302-0118 | |
| 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. | |
| Ishikawa, Japan, 920-8641 | |
| 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, Japan, 235-0045 | |
| 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. | |
| Kumamoto, Japan, 862-0976 | |
| 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. | |
| Miyagi, Japan, 980-0021 | |
| 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, Japan, 399-0006 | |
| 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, Japan, 532-0003 | |
| 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, Japan, 160-0022 | |
| 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, Japan, 939-0363 | |
| 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. | |
| Yamaguchi, Japan, 756-0095 | |
| 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. | |
| Yokohama, Japan, 220-0012 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
No publications provided
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT01558271 History of Changes |
| Other Study ID Numbers: | 13990, H9X-JE-GBDP |
| Study First Received: | March 12, 2012 |
| Last Updated: | May 15, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Eli Lilly and Company:
|
GLP-1 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glucagon-Like Peptide 1 |
Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013