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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01468181
First received: November 7, 2011
Last updated: December 20, 2013
Last verified: December 2013
  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
Study Completion Date: December 2013
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: December 20, 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 April 17, 2014