Phase
Condition
Diabetes Prevention
Diabetes And Hypertension
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with DM type 2, age at least 18 years, both genders.
T2DM patients who have been diagnosed for > 1 year, and have been treated with oneoral antidiabetic at stable doses for > 3 months prior to screening, have BMI of 18.0to 35.0 kg/m2 inclusive, and HbA1C of > 7.0% and insulin-naive.
Patients who are cooperative, reliable, and agree to have regular injections ofinsulin, and are willing to comply with protocol procedure (willing to sign theinformed consent).
Female patients with adequate protection from conception. Females of childbearingpotential must use a reliable method of birth control during the study (barrier-methodor IUD). Women with history of bilateral tubal ligation, or with total hysterectomy,or who are 2 years postmenopausal are also eligible.
Exclusion
Exclusion Criteria:
Pregnancy (confirmed by a positive urine pregnancy test) or lactation.
History of severe hypoglycemia during the last year (blood glucose level <50 mg/dlwith transient dysfunction of central nervous system without other apparent cause)
History of diabetic ketoacidosis > 2x within the last year.
Having hyperglycemia hyperosmolar status (HHS)
Renal impairment (eGFR < 30 mL/min).
An employee of the Investigator or the Sponsor.
Participating in another clinical study within the past 3 months.
Receiving any immunosuppressants, including corticosteroids or cytostatics within thelast year or during the study.
Receiving any drug or supplement with hypoglycemic activity (except oralantidiabetics) within 4 weeks prior to screening and during the study.
Receiving any drug with hyperglycemic activity within 4 weeks prior to screening andduring the study (eg. second generation antipsychotics, corticosteroids, tacrolimus,protease inhibitors).
Have undergone pancreatectomy or pancreas / islet cell transplant.
Mental disorder
Any malignancies
Study Design
Study Description
Connect with a study center
Department of Internal Medicine Cipto Mangunkusumo General Hospital, Faculty of Medicine Universitas Indonesia
Jakarta Pusat, Jakarta 10520
IndonesiaSite Not Available

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