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:
NCT01468181
First received: November 7, 2011
Last updated: May 15, 2013
Last verified: May 2013
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: LY2189265 Drug: Sulfonylureas (SU) Drug: Biguanides Drug: Thiazolidinedione (TZD) Drug: alpha-glucosidase inhibitor (a-GI) Drug: Glinides |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A 52-Week, Open-Label, Long-Term Safety Study of LY2189265 in Combination With Monotherapy of Oral Antihyperglycemic Medications 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:
- Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline through 52 Weeks ] [ Designated as safety issue: Yes ]
- Percentage of Participants with Hypoglycemic Episodes [ Time Frame: Baseline through 52 Weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change from Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
- Percentage of Participants Who Achieve HbA1c <=6.5% or <7% [ Time Frame: 26 weeks and 52 weeks ] [ Designated as safety issue: Yes ]
- Change from Baseline in Fasting Blood Glucose (FBG) [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
- Change from Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
- Change from Baseline in Body Weight [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
- Change from Baseline in Updated Homeostasis Model Assessment (HOMA 2) [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 365 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sulfonylureas (SU)+ LY2189265
Add LY2189265 to participant's pre-study physician prescribed dose of SU monotherapy
|
Drug: LY2189265
0.75 mg administered by subcutaneous injection once weekly for 52 weeks
Other Name: dulaglutide
Drug: Sulfonylureas (SU)
SU is pre-study prescribed dose, and is not being provided as part of the trial.
|
|
Experimental: Biguanides+ LY2189265
Add LY2189265 to participant's pre-study physician prescribed dose of Biguanides
|
Drug: LY2189265
0.75 mg administered by subcutaneous injection once weekly for 52 weeks
Other Name: dulaglutide
Drug: Biguanides
Biguanides is pre-study prescribed dose, and is not being provided as part of the trial.
|
|
Experimental: Thiazolidinedione (TZD)+ LY2189265
Add LY2189265 to participant's pre-study physician prescribed dose of TZD monotherapy
|
Drug: LY2189265
0.75 mg administered by subcutaneous injection once weekly for 52 weeks
Other Name: dulaglutide
Drug: Thiazolidinedione (TZD)
TZD is pre-study prescribed dose, and is not being provided as part of the trial.
|
|
Experimental: alpha-glucosidase inhibitor (a-GI)+LY2189265
Add LY2189265 to participant's pre-study physician prescribed dose of a-GI monotherapy
|
Drug: LY2189265
0.75 mg administered by subcutaneous injection once weekly for 52 weeks
Other Name: dulaglutide
Drug: alpha-glucosidase inhibitor (a-GI)
a-GI is pre-study prescribed dose, and is not being provided as part of the trial.
|
|
Experimental: Glinides+ LY2189265
Add LY2189265 to participant's pre-study physician prescribed dose of Glinides monotherapy
|
Drug: LY2189265
0.75 mg administered by subcutaneous injection once weekly for 52 weeks
Other Name: dulaglutide
Drug: Glinides
Glinides is pre-study prescribed dose, and is not being provided as part of the trial.
|
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 taking SU (Glibenclamide, Gliclazide, Glimepiride), biguanides, 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 kg/m^2 to 35.0 kg/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 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01468181
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. | |
| Aichi, Japan, 466-0815 | |
| 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, Japan, 277-0825 | |
| 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, 050-0073 | |
| 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, 662-0971 | |
| 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, 300-0053 | |
| 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, 231-0023 | |
| 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, Japan, 615-8125 | |
| 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, 390-1401 | |
| 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, Japan, 700-8558 | |
| 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, 560-0082 | |
| 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, Japan, 3438577 | |
| 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, 1030002 | |
| 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, 930-0859 | |
| 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, Japan, 644-0011 | |
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 9AM-5PM 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: | NCT01468181 History of Changes |
| Other Study ID Numbers: | 13991, H9X-JE-GBDQ |
| Study First Received: | November 7, 2011 |
| Last Updated: | May 15, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Eli Lilly and Company:
|
Type 2 diabetes mellitus Oral antihyperglycemic medications Long-Term Safety GLP 1 Glucagon like peptide 1 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
2,4-thiazolidinedione Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013