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Completed

NCT Number: NCT03338023

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

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).

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University Peoples Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

LY2963016

Drug

Administered SC

Lantus®

Drug

Administered SC

Insulin Lispro

Drug

Administered SC

Primary outcomes

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

    Time frame: Baseline, Week 24

    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).

Secondary outcomes

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

    Time frame: Baseline, Week 24

    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).

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

    Time frame: Baseline, Week 24

    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).

  3. Percentage of Participants With HbA1c <7%

    Time frame: Week 24

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

  4. Percentage of Participants With HbA1c ≤6.5%

    Time frame: Week 24

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

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

    Time frame: Baseline, Week 24

    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).

  6. Change From Baseline in Glycemic Variability of Fasting Blood Glucose

    Time frame: Baseline, Week 24

    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).

  7. Change From Baseline in Basal Insulin Dose

    Time frame: Baseline, Week 24

    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.

  8. Change From Baseline in Prandial Insulin Dose

    Time frame: Baseline, Week 24

    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.

  9. Change From Baseline in Body Weight

    Time frame: Baseline, Week 24

    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.

  10. Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ)

    Time frame: Baseline, Week 24

    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).

  11. Number of Participants With Detectable Anti-Glargine Antibodies

    Time frame: Baseline through Week 24

    Number of participants with detectable anti-glargine antibodies

  12. Rate of Documented Symptomatic Hypoglycemia

    Time frame: Baseline through Week 24

    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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Prospective, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog, LY2963016, to Lantus® in Combination With Mealtime Insulin Lispro in Adult Chinese Patients With Type 1 Diabetes Mellitus

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 9, 2017
Registry last updated
Mar 29, 2021

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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