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Completed

NCT Number: NCT03338010

A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 2 Diabetes Mellitus

The purpose of this study is to compare long-acting basal insulin analog LY2963016 to Lantus® in insulin naïve adult Chinese participants with Type 2 Diabetes Mellitus (T2DM) on 2 or more oral antihyperglycemic medications (OAMs). Participants will continue their OAMs throughout the study.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anhui Provincial Hospital, Hefei, Anhui, 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 T2DM based on the disease diagnostic criteria World Health Organization (WHO) classification.
  • Have been receiving 2 or more OAMs at stable doses for the 12 weeks prior to screening.
  • Have a HbA1c ≥7.0% and ≤11.0%.
  • Body mass index (BMI) ≤35 kilograms per meter squared.

Exclusion criteria

  • Have used insulin therapy (outside of pregnancy) anytime in the past 1 year, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks.
  • Have used any glucagon like peptide (GLP-1) receptor agonists within the previous 90 days.
  • Are currently taking traditional medicine (herbal medicine or patent medicine) with known/specified content of anti-hyperglycemic effects within 3 months before screening.
  • Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.
  • Have had ≥2 emergency room visits or hospitalizations due to poor glucose control.
  • Have known hypersensitivity or allergy to Lantus® or its excipients.
  • Are receiving chronic systemic glucocorticoid therapy at pharmacological doses or have received such therapy within 4 weeks immediately preceding screening.
  • Have obvious signs or symptoms, or laboratory evidence, of liver disease.
  • Have one of the following concomitant diseases: significant cardiac or gastrointestinal disease.
  • Have a history of renal transplantation, are currently receiving renal dialysis or have a serum creatinine greater than 2.0 milligrams per deciliter.
  • Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia.
  • Participants with active cancer or personal history of cancer within the previous 5 years.
  • Are pregnant or intend to become pregnant during the course of the study.
  • Are women who are breastfeeding.

Treatment and study plan

LY2963016

Drug

Administered SC

Lantus®

Drug

Administered SC

Primary outcomes

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

    Time frame: Baseline, Week 24

    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least square (LS) mean was calculated by mixed-effects model for repeated measures (MMRM) with baseline, insulin secretagogues at study entry, treatment, visit and treatment*visit in the model.

Secondary outcomes

  1. Change From Baseline in HbA1c (Lantus® 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 by MMRM with baseline, insulin secretagogues at study entry, treatment, visit and treatment*visit in the model.

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

    Time frame: Baseline, Week 24

    Seven-point SMBG are completed at the following timepoints: Before Morning Meal, 2 Hours After Morning Meal, Before Mid-Day Meal, 2 Hours After Mid-Day Meal, Before Evening Meal, 2 Hours After Evening Meal and Bed Time. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment*time in the model.

  3. Percentage of Participants With HbA1c <7% at Week 24

    Time frame: Week 24

    The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.

  4. Percentage of Participants With HbA1c ≤6.5% at Week 24

    Time frame: Week 24

    The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.

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

    Time frame: Baseline, Week 24

    Glycemic variability is measured by the intra-participant standard deviation (SD) value of fasting blood glucose as measured by the actual morning and daily pre-meal blood glucose value from the 7-point self-monitoring blood glucose [SMBG] profiles. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment*time in the model.

  6. Basal Insulin Dose Units Per Day

    Time frame: At Week 24

    Units of basal insulin dose taken per day (U/day). LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment*time in the model.

  7. Change From Baseline in Basal Insulin Dose Units Per Day

    Time frame: Baseline, Week 24

    Units of basal insulin dose taken per day (U/day). LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment*time in the model.

  8. Change From Baseline in Body Weight

    Time frame: Baseline, Week 24

    Change from baseline in body weight was evaluated. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment*time in the model.

  9. Insulin Treatment Satisfaction Questionnaire (ITSQ)

    Time frame: At Week 24

    ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items divided into 5 domains of satisfaction: Inconvenience of Regimen [(IR) 5 items: domain scores range (DSR) 5-35], Lifestyle Flexibility [(LF) 3 items: DSR 3-21], Glycemic Control [(GC) 3 items: DSR 3-21], Hypoglycemic Control [(HC) 5 items: DSR 5-35], Insulin Delivery Device [(IDD) 6 items: DSR 6-42]. All items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. ITSQ Total Overall Raw Scores range from 22-154. Both raw domain and overall scores are transformed on a scale of 0-100, where transformed score=100*[(7-mean raw score)/6]. Higher scores indicate better treatment satisfaction. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment*time in the model.

  10. Number of Participants With Detectable Anti-Glargine Antibodies

    Time frame: Baseline through 24 weeks

    Number of participants with detectable anti-glargine antibodies were reported.

  11. Rate of Total Symptomatic and Nocturnal Hypoglycemia Events (Adjusted by 1 Year)

    Time frame: Baseline through 24 weeks

    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 (participant's treatment duration/365.25) as an offset variable. A nocturnal hypoglycemic event is defined as any total hypoglycemia event that occurred between bedtime and waking.

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 Adult Chinese Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 9, 2017
Registry last updated
May 25, 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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