Diabetes Mellitus, Type 1Phase 1NCT02506647
PK/PD Study of Gan & Lee's Insulin Glargine Injection in Comparison to Lantus in Type 1 Diabetes
A Phase 1 study testing Gan & Lee insulin glargine followed by Lantus and Lantus followed by Gan & Lee insulin glargine in people with Diabetes Mellitus, Type 1, run by Gan and Lee Pharmaceuticals, USA at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Gan & Lee insulin glargine followed by Lantus and Lantus followed by Gan & Lee insulin glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Sep 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 23Show fewer
- 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.
- Personal or family history of hypercoagulability or thromboembolic disease.
- History of any active infection, other than mild or viral illness within 30 days prior to dosing as judged by the Investigator.
- History of alcohol or illicit/recreational drug abuse as judged by the Investigator within approximately 1 year. (Use of up to 1000 mL beer, 500 mL wine, or 100 mL distilled spirits is allowed).
- Smoking > 10 cigarettes or equivalent use of any tobacco product (e.g.nicotine patch) within 6 months prior to Screening. Subjects must be able to refrain from smoking at least 1 week prior to admission and during each in-house period.
- Known history of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus type 1 (HIV-1) or 2 (HIV-2) antibody.
- Existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution or metabolism of the drugs or the tolerability/safety measurements.
- Presence of clinically significant physical, laboratory, or electrocardiogram (ECG) findings (e.g., QTcF > 470 msec for females, > 450 msec for males, LBBB) at Screening that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results.
- Donation or loss of > 500 mL of blood or blood product within 56 days of dosing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Profil Institute for Clinical Research
San Diego, California, 91911
About this study
Official title: A Phase 1, Exploratory, Randomized, Double-Blind, Two-Way Cross Over Study to Assess Pharmacokinetic and Pharmacodynamic Effects of Gan & Lee's Insulin Glargine Injection in Comparison to Lantus in Subjects With Type 1 Diabetes Mellitus
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
- Being tested
- Gan & Lee insulin glargine followed by Lantus, Lantus followed by Gan & Lee insulin glargine
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gan & Lee insulin glargine followed by LantusDrug
0.4 IU/kg Gan \& Lee insulin glargine injection SC, Lantus 0.4 IU/kg injection SC
Lantus followed by Gan & Lee insulin glargineDrug
Lantus 0.4 IU/kg injection SC, 0.4 IU/kg Gan \& Lee insulin glargine injection SC,
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Gan \& Lee insulin glargine followed by Lantus Receives: Drug: Gan & Lee insulin glargine followed by Lantus |
| Sequence 2 | Active comparator | Lantus followed by Gan \& Lee insulin glargine Receives: Drug: Lantus followed by Gan & Lee insulin glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamic effects
Pharmacodynamic effects: Area under the glucose infusion rate, AUC GIR(0-24hr)
Measured: 0-24 hours
Pharmacokinetic effects
Area under the insulin concentration-time curve, AUCINS (0-24hr)
Measured: 0-24 hours
Secondary outcomes (5)
Pharmacokinetic effects
AUCINS (0-12hr)
Measured: 0-12 hours
Pharmacokinetic effects
AUCINS (12-24hr)
Measured: 12-24 hours
Pharmacodynamic effects
AUCGIR (0-12hr)
Measured: 0-12hours
Pharmacodynamic effects
AUCGIR (12-24hr)
Measured: 12-24 hours
Safety assessment as measured by incidence and severity of adverse events
Incidence and severity of adverse events
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startDec 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gan and Lee Pharmaceuticals, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marcus Hompesch, MD, Principal investigator, Profil Institute for Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506647
- Sponsor's protocol ID
- GL-GLA-001
- Status last verified
- Jan 2017
- First submitted
- 16 Jul 2015
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Exploratory, Randomized, Double-Blind, Two-Way Cross Over Study to Assess Pharmacokinetic and Pharmacodynamic Effects of Gan & Lee's Insulin Glargine Injection in Comparison to Lantus in Subjects With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02506647
- Acronym / sponsor ID
- GL-GLA-001
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Gan and Lee Pharmaceuticals, USAIndustry (pharma, biotech, devices)
- Study start
- Dec 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 23 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Gan & Lee insulin glargine followed by LantusGan \& Lee insulin glargine followed by Lantus |
| Sequence 2 | Active comparator | Drug: Lantus followed by Gan & Lee insulin glargineLantus followed by Gan \& Lee insulin glargine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gan & Lee insulin glargine followed by Lantus0.4 IU/kg Gan \& Lee insulin glargine injection SC, Lantus 0.4 IU/kg injection SC | Drug | Sequence 1 |
| Lantus followed by Gan & Lee insulin glargineLantus 0.4 IU/kg injection SC, 0.4 IU/kg Gan \& Lee insulin glargine injection SC, | Drug | Sequence 2 |
Primary outcome
Pharmacodynamic effects
Time frame: 0-24 hours
Pharmacodynamic effects: Area under the glucose infusion rate, AUC GIR(0-24hr)
Pharmacokinetic effects
Time frame: 0-24 hours
Area under the insulin concentration-time curve, AUCINS (0-24hr)
5 secondary outcomes
Pharmacokinetic effects
Time frame: 0-12 hours
Pharmacokinetic effects
Time frame: 12-24 hours
Pharmacodynamic effects
Time frame: 0-12hours
Pharmacodynamic effects
Time frame: 12-24 hours
Safety assessment as measured by incidence and severity of adverse events
Time frame: 0-24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
Related trials for Diabetes Mellitus, Type 1
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Hompesch, MD principal investigator
Profil Institute for Clinical Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gan & Lee insulin glargine followed by Lantus and Lantus followed by Gan & Lee insulin glargine in people with Diabetes Mellitus, Type 1, run by Gan and Lee Pharmaceuticals, USA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacodynamic effects (time frame: 0-24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.