A Phase 2, 12-Week, Double-Blind, Efficacy and Safety of GX-G6 in Patients With Uncontrolled Type 2 Diabetes Mellitus
NCT ID: NCT03962010
Last Updated: 2019-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
78 participants
INTERVENTIONAL
2019-06-01
2022-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dose level 1
GX-G6
long acting anti-diabetic drug
Dose level 2
GX-G6
long acting anti-diabetic drug
Dose level 3
GX-G6
long acting anti-diabetic drug
Dose level 4
GX-G6
long acting anti-diabetic drug
Placebo
Control
Control
Dulaglutide
Control
Control
Interventions
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GX-G6
long acting anti-diabetic drug
Control
Control
Eligibility Criteria
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Inclusion Criteria
2. HbA1c level of 7-10% (inclusive)
Exclusion Criteria
2. History of severe hypoglycaemia defined as ≥ 2 episodes of severe hypoglycaemia within 6 months prior to screening
3. Have had ≥ 2 episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization in the 6 months prior to screening
4. Has fasting serum TG ≥ 500 mg/dL or 9 mmol/L at screening.
5. Patients receiving lipid-lowering therapy must have been on the same dose of therapy for the past three months
18 Years
ALL
No
Sponsors
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Genexine, Inc.
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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GX-G6-002
Identifier Type: -
Identifier Source: org_study_id
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