A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 1 Diabetes Mellitus

Eli Lilly and Company272 enrolled

Overview

The purpose of this study is to compare long-acting basal insulin analog LY2963016 to Lantus® in combination with mealtime insulin lispro in adult Chinese participants with Type 1 Diabetes Mellitus (T1DM).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

272

Conditions

Type 1 Diabetes

Interventions

LY2963016DRUG

Administered SC

Lantus®DRUG

Administered SC

Insulin LisproDRUG

Administered SC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have T1DM based on the disease diagnostic criteria (World Health Organization \[WHO\] Classification). * Have duration of T1DM ≥1 year. * Have HbA1c ≤11 %. * Have been administered with basal-bolus insulins or pre-mixed insulins for at least 90 days prior to screening. * Have a body mass index (BMI) ≤35 kilograms per meter squared. Exclusion Criteria: * Exposure to an insulin glargine other than Lantus® within previous 30 days. * Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study. * Have had more than one episode of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within 6 months prior to entry into the study. * Have known hypersensitivity or allergy to any of the study insulins (Lantus® or insulin lispro) or to excipients of the study insulins. * Are pregnant, intend to become pregnant during the course of the study. * Women who are breastfeeding. * Are currently taking traditional medicine (herbal medicine or patent medicine) with known/specified content of anti-hyperglycemic effects within 3 months before screening. * Have congestive heart failure Class III and IV. * Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease. * Have any active cancer. * Have a history or diagnosis of human immunodeficiency virus (HIV) infection. * Have presence of clinically significant gastrointestinal disease. * Have a history of renal transplantation, or are currently receiving renal dialysis. * Are receiving chronic systemic glucocorticoid therapy at pharmacological doses.

Locations (20)

Peking University Peoples Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 Noninferior to Lantus®)

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean was calculated using mixed-effects model for repeated measures (MMRM) with variables baseline HbA1c + Treatment + Pre-study treatment + Pre-study metformin or acarbose usage + Time + Time\*Treatment (Type III sum of squares).

Time frame: Baseline, Week 24

Secondary Outcomes

Change From Baseline in HbA1c (Lantus® Noninferior to LY2963016)

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean was calculated using MMRM with variables baseline HbA1c + Treatment + Pre-study treatment + Pre-study metformin or acarbose usage + Time + Time\*Treatment (Type III sum of squares).

Time frame: Baseline, Week 24

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

The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Before Morning Meal Glucose, 2 Hours After Morning Meal Glucose, Before Mid-Day Meal Glucose, 2 Hours After Mid-Day Meal Glucose, Before Evening Meal Glucose, Bedtime Glucose and 0300 Am Glucose. LS mean was calculated using MMRM with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares).

Time frame: Baseline, Week 24

Percentage of Participants With HbA1c <7%

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.

Time frame: Week 24

Percentage of Participants With HbA1c ≤6.5%

Data from ClinicalTrials.gov

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Guangdong Province People's Hospital

Guangzhou, Guangdong, China

The First Affiliated Hospital, Sun-Yat Sen University

Guangzhou, Guangdong, China

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Shantou University Medical College No.2 Affiliated Hospital

Shantou, Guangdong, China

The 1st Affiliated Hospital of Henan Science and technology

Luoyang, Henan, China

Wu Han Tongji Hospital

Wuhan, Hubei, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Changzhou No.2 People's Hospital

Changzhou, Jiangsu, China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

...and 10 more locations

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.

Change From Baseline in Intrapatient Blood Glucose (BG) Variability, Measured by the Standard Deviation of 7-point SMBG

Change From Baseline in Intrapatient blood glucose (BG). LS mean was calculated using MMRM with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares).

Time frame: Baseline, Week 24

Change From Baseline in Glycemic Variability of Fasting Blood Glucose

Change From Baseline in Glycemic Variability of Fasting Blood Glucose. LS mean was calculated using MMRM with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares).

Time frame: Baseline, Week 24

Change From Baseline in Basal Insulin Dose

Change from baseline in basal insulin dose. LS mean was calculated using MMRM with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Measurement) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.

Time frame: Baseline, Week 24

Change From Baseline in Prandial Insulin Dose

Prandial Insulin Dose. LS mean was calculated using MMRM with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Measurement) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.

Time frame: Baseline, Week 24

Change From Baseline in Body Weight

Change from baseline in body weight. LS mean was calculated using MMRM with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Measurement) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.

Time frame: Baseline, Week 24

Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ)

The ITSQ is a validated 22-item questionnaire that was used to assess treatment satisfaction. Items were measured on a 7-point scale, with lower scores reflecting better outcomes. In addition to an overall score, scores were also obtained for 5 domains, including inconvenience of regimen, lifestyle flexibility, glycemic control, hypoglycemic control, and insulin delivery device. Raw domain and overall scores were transformed on a scale from 0 to 100, where a higher score indicated better treatment satisfaction. LS mean was calculated using ANCOVA with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment (Type III sum of squares).

Time frame: Baseline, Week 24

Number of Participants With Detectable Anti-Glargine Antibodies

Number of participants with detectable anti-glargine antibodies

Time frame: Baseline through Week 24

Rate of Documented Symptomatic Hypoglycemia

Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L). The overall yearly rates (events/participant/year) of those hypoglycemic events, calculated as, for each participant, the number of episodes times 365.25 and then divided by the participants treatment duration, will be summarized, and analyzed by a Negative-binomial regression model with treatment as fixed effects and log of (patient's treatment duration/365.25) as an offset variable.

Time frame: Baseline through Week 24