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: January 16, 2015
Last verified: January 2015
  Purpose

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).


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: LY2189265
Drug: Sulfonylureas (SU)
Drug: Biguanides (BG)
Drug: alpha-glucosidase inhibitor (a-GI)
Drug: Thiazolidinedione (TZD)
Drug: Glinides
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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 ]
    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.

  • Percentage of Participants With Hypoglycemic Episodes [ Time Frame: Baseline through 52 Weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, up to 26 Weeks and up to 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, up to 26 weeks and up to 52 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) [ Time Frame: Baseline, up to 26 weeks and up to 52 weeks ] [ Designated as safety issue: No ]
    Participants were to test and record SMBG concentrations in their study diaries before each meal (breakfast, lunch, and dinner), approximately 2 hours after the start of each meal. For the mean of all 7-point blood glucose values, the daily mean was calculated as the average of 7 blood glucose values collected on a particular day. The mean of all 7-point blood glucose values at each visit was calculated as the average of 2 daily means. The change from baseline was calculated as the mean of all 7-point blood glucose values at endpoint minus the mean of all 7-point blood glucose values at baseline.

  • Change From Baseline in Body Weight [ Time Frame: Baseline, up to 26 weeks and up to 52 weeks ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Updated Homeostasis Model Assessment (HOMA2) [ Time Frame: Baseline, up to 26 weeks and up to 52 weeks ] [ Designated as safety issue: No ]
    The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S).


Enrollment: 394
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: LY2189265 + Sulfonylureas (SU)

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
Other Name: Dulaglutide
Drug: Sulfonylureas (SU)
SU is a pre-study prescribed dose and is not being provided as part of the trial.
Experimental: LY2189265 + Biguanides (BG)

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
Other Name: Dulaglutide
Drug: Biguanides (BG)
Biguanides is a pre-study prescribed dose and is not being provided as part of the trial.
Experimental: LY2189265 + alpha-glucosidase inhibitor (a-GI)

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
Other Name: Dulaglutide
Drug: alpha-glucosidase inhibitor (a-GI)
a-GI is a pre-study prescribed dose and is not being provided as part of the trial.
Experimental: LY2189265 + Thiazolidinedione (TZD)

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
Other Name: Dulaglutide
Drug: Thiazolidinedione (TZD)
TZD is a pre-study prescribed dose and is not being provided as part of the trial.
Experimental: LY2189265 + Glinides

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
Other Name: Dulaglutide
Drug: Glinides
Glinides is a 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), 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)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: December 8, 2014
Last Updated: January 16, 2015
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
2,4-thiazolidinedione
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 28, 2015