PK/PD Study of Gan & Lee's Insulin Glargine Injection in Comparison to Lantus in Type 1 Diabetes

NCT02506647 | Completed Phase 1

• 1 other identifier: GL-GLA-001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, exploratory, single dose, randomized, double-blind, two-way cross over, pilot, glucose clamp study to assess pharmacokinetic and pharmacodynamic effects of Gan \& Lee's insulin glargine injection in comparison to the marketed Lantus (US) in subjects with type 1 diabetes mellitus (T1DM).

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

• Pharmacodynamic effects

  Pharmacodynamic effects: Area under the glucose infusion rate, AUC GIR(0-24hr)

  0-24 hours

• Pharmacokinetic effects

  Area under the insulin concentration-time curve, AUCINS (0-24hr)

  0-24 hours

Secondary Outcomes (5)

• Pharmacokinetic effects

  0-12 hours

• Pharmacokinetic effects

  12-24 hours

• Pharmacodynamic effects

  0-12hours

• Pharmacodynamic effects

  12-24 hours

• Safety assessment as measured by incidence and severity of adverse events

  0-24 hours

Study Arms (2)

Sequence 1

EXPERIMENTAL

Gan \& Lee insulin glargine followed by Lantus

Drug: Gan & Lee insulin glargine followed by Lantus

Sequence 2

ACTIVE COMPARATOR

Lantus followed by Gan \& Lee insulin glargine

Drug: Lantus followed by Gan & Lee insulin glargine

Interventions

Gan & Lee insulin glargine followed by Lantus DRUG

0.4 IU/kg Gan \& Lee insulin glargine injection SC, Lantus 0.4 IU/kg injection SC

Sequence 1

Lantus followed by Gan & Lee insulin glargine DRUG

Lantus 0.4 IU/kg injection SC, 0.4 IU/kg Gan \& Lee insulin glargine injection SC,

Sequence 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female and Male subjects with T1DM, duration ≥12 months.
• Adults ≥ 18 to ≤ 65 years of age.
• Body mass index (BMI) ≥ 18.5 to ≤ 30.0 kg/m2.
• Weight ≥ 50 kg.
• Fasting serum C-peptide ≤ 0.4 nmol/L, assessed at a plasma glucose concentration \> 90mg/dL.
• HbA1c ≤ 9.5%.
• Current stable treatment with insulin (consistent therapy with multiple daily injections with basal and bolus insulin or CSII).
• Current stable dose of insulin (± 20% difference in total daily insulin dose) over the 2-week period prior to screening; total daily dose ≤ 1.2 IU/kg.
• Female subjects must be non-pregnant and non-lactating. For postmenopausal females (no menses \>12 months); postmenopausal status will be confirmed through testing of FSH levels ≥ 40 IU/mL at screening for subjects \<55 years of age.
• Ability to provide written informed consent.

You may not qualify if:

• A subject who has proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator.
• History of ≥ 2 episodes of severe hypoglycemia (as defined per ADA criteria) or ≥ 1 episodes of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within 6 months prior to screening.
• Subjects is on a carbohydrate restricted diet (i.e., a diet \< 100 grams per day of carbohydrate).
• Systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 95 mmHg at screening. Treatment with no more than 2 antihypertensive medications must be with stable doses for at least 3 months prior to screening.
• Current use of any drugs (other than insulin) that are known to interfere with glucose or insulin metabolism, including but not limited to oral corticosteroids, monoamino oxidase (MAO) inhibitors, growth hormone and non-selective β-blockers, loop diuretics.
• Thyroid hormone use not stable during the past 3 months prior to dosing.
• Hyperlipidemia treatment not on stable dose for ≥ 3 months prior to dosing. (HMG-CoA reductase inhibitor (statin), a fibrate (i.e. fenofibrate, gemfibrozil) and ezetimibe are allowed as treatment).
• Any use of non-steroid anti-inflammatory drugs (NSAIDs) except for low-dose Aspirin is not allowed within 7 days prior to dosing and on the dosing day.
• Participation in an investigational study within 30 days prior to dosing or 5 half-lives within the last dose of investigational product whichever is longer.
• History of any major surgery within 6 months prior to screening.
• History of any serious adverse reaction or hypersensitivity to insulin, insulin analogue, any of the product components, or chemically related products.
• History of renal disease or abnormal kidney function tests at screening (glomerular filtration rate (GFR) \< 60 mL/min/1.73m2 ).
• Clinically significant abnormal hematology or biochemistry screening tests.
• Any history of heart disease, defined as symptomatic heart failure (New York Heart Association class III or IV), myocardial infarction, coronary artery bypass graft surgery, or angioplasty, unstable angina requiring medication, transient ischemic attack, cerebral infarct, or cerebral hemorrhage.
• History of any clinically significant gastrointestinal, cardiovascular, hematological, psychiatric, renal, hepatic, pancreatic or neurological abnormality as judged by the Investigator.

Sponsors & Collaborators

• Gan and Lee Pharmaceuticals, USA: lead

Study Sites (1)

Profil Institute for Clinical Research

San Diego, California, 91911, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

gallium nitrate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Marcus Hompesch, MD

  Profil Institute for Clinical Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2015
• First Posted: July 23, 2015
• Study Start: December 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 26, 2017

Record last verified: 2017-01

Locations

US (1)