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OpenTrials
Completed

NCT Number: NCT01468181

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

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).

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary 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., Aichi, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

LY2189265

Drug

Other names: Dulaglutide

Sulfonylureas (SU)

Drug

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

Biguanides (BG)

Drug

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

alpha-glucosidase inhibitor (a-GI)

Drug

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

Thiazolidinedione (TZD)

Drug

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

Glinides

Drug

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

Primary outcomes

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

    Time frame: Baseline through 52 Weeks

    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.

  2. Percentage of Participants With Hypoglycemic Episodes

    Time frame: Baseline through 52 Weeks

    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 outcomes

  1. Change From Baseline in Glycosylated Hemoglobin (HbA1c)

    Time frame: Baseline, up to 26 Weeks and up to 52 Weeks

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

    Time frame: 26 weeks and 52 weeks

  3. Change From Baseline in Fasting Blood Glucose (FBG)

    Time frame: Baseline, up to 26 weeks and up to 52 weeks

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

    Time frame: Baseline, up to 26 weeks and up to 52 weeks

    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.

  5. Change From Baseline in Body Weight

    Time frame: Baseline, up to 26 weeks and up to 52 weeks

  6. Change From Baseline in Updated Homeostasis Model Assessment (HOMA2)

    Time frame: Baseline, up to 26 weeks and up to 52 weeks

    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).

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 9, 2011
Registry last updated
Jan 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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