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Completed

NCT Number: NCT03736785

A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes that have already been treated with basal insulin.

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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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Universitario UANL, Monterrey, Nuevo León, Mexico

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with basal insulin and up to 3 of the following oral antihyperglycemic medication (OAM):
  • dipeptidyl peptidase-4 (DPP-4) inhibitors
  • sodium-glucose cotransporter (SGLT-2) inhibitors
  • biguanides
  • alpha-glucosidase inhibitors
  • sulfonlyureas
  • HbA1c value of 6.5% to 10%, inclusive
  • Body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m2), inclusive

Exclusion criteria

  • Type 1 diabetes mellitus or latent autoimmune diabetes
  • Any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
  • Any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)
  • Acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
  • Estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m2
  • Active or untreated malignancy
  • Chronic (>14 days) systemic glucocorticoid therapy

Treatment and study plan

LY3209590

Drug

Administered SC

insulin degludec

Drug

Administered SC

Primary outcomes

  1. Change From Baseline in HbA1c

    Time frame: Baseline, Week 32

    HbA1c is the glycosylated fraction of haemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

    Change from baseline in HbA1c was analysed by mixed model repeated measures (MMRM) including fixed effects of treatment, stratification factors (country, BMI group [> 30 or ≤ 30], sulfonylureas use at study entry), visit and treatment by visit interaction and baseline HbA1c as the covariate.

Secondary outcomes

  1. Change From Baseline in HbA1c Compared to Insulin Degludec

    Time frame: Baseline, Week 32

    HbA1c is the glycosylated fraction of haemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

    Change from baseline in HbA1c was analysed by MMRM including fixed effects of treatment, stratification factors (country, BMI group [> 30 or ≤ 30], sulfonylureas use at study entry), visit and treatment by visit interaction, and baseline HbA1c as the covariate.

  2. Change From Baseline in Fasting Glucose

    Time frame: Baseline, Week 32

    Change from baseline in fasting glucose was analysed by MMRM including fixed effects of treatment, stratification factors (country, BMI group [> 30 or ≤ 30], sulfonylureas use at study entry, HbA1c strata [<8.5% or ≥8.5%]), visit and treatment by visit interaction, and baseline fasting glucose as the covariate.

  3. Change From Baseline in Insulin Dose (LY3209590)

    Time frame: Week 1, Week 32

    The baseline for both LY3209590 arms was the first regular weekly dose at Week 1.

  4. Change From Baseline in Insulin Dose (Insulin Degludec)

    Time frame: Baseline, Week 32

    Change from Baseline in Insulin Dose for Insulin Degludec arm was reported.

  5. Rate of Total Documented Symptomatic Hypoglycemia

    Time frame: Baseline through week 32

    The hypoglycemia events were defined by participant reported events with glucose ≤54 mg/dL (3.0 millimole per liter (mmol/L)). Relative Rate was calculated based on Group Mean. Group Mean was estimated by first taking the inverse link function on individual patient covariates, then averaging over all participants.

  6. Change From Baseline in Body Weight

    Time frame: Baseline, Week 32

    Change from baseline in body weight was analysed by MMRM including fixed effects of treatment, visit and treatment by visit interaction, and baseline body weight as the covariate.

  7. Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590

    Time frame: Week 32

    PK: AUC of LY3209590 was reported for LY3209590 Algorithm 1 and LY3209590 Algorithm 2 arms. AUC was calculated for individual participants using the participant's Week 32 LY3209590 dose amount and the participant's estimated clearance value.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 2, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of LY3209590 in Study Participants With Type 2 Diabetes Mellitus Previously Treated With Basal Insulin

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 9, 2018
Registry last updated
Mar 8, 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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