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In healthy human volunteers; study ‎of Insulin Glargine (Basagine™) after single ‎subcutaneous injection of 0.2 unit/Kg dose; compared with nothing ‎and primarily to establish the PK parameters Cmax, ‎Tmax and AUC in Pakistani population.‎

Protocol summary

Summary
Study Title: Pharmacokinetic evaluation of Insulin-Glargine (rDNA origin) 100 u/ml (Basagine™) in local healthy human volunteers after administration of a 0.2 units/Kg subcutaneous dose. Study Design: Open label, single period, single treatment, and single dose study in fourteen healthy volunteers. Goal/Objective: To determine AUC0–t, Cmax and, Tmax of the drug in Pakistani population Inclusion Criteria: Healthy male/female, Age: 18 to 50 years, BMI: 18-26 Kg/m2, Fasting plasma glucose: <6.0 mmol/l, non-smoker, non-alcoholic and no drug abuse. Exclusion criteria: Volunteers with any neuropathy, diabetes mellitus, Hypertension and any Cardio Vascular disease, positive test results for HBsAg, anti HCV and HIV antibody. Findings of hematology, biochemistry and ECG are out of range revealing clinical significance. Treatments: Single subcutaneous dose of Insulin-Glargine (rDNA origin; Basagine™) 0.2 units/Kg. Afterwards 5ml blood would be collected at 30 min, 15 min and 0 min before and 1, 2, 3, 4, 6, 8, 12, 16, 20, 22, 23, 24, 25 hours after drug administration. 120-240 ml 20% glucose will be given orally every 30 minutes to keep the blood glucose levels above 100mg/dl. Safety: Through physical examination, vital sign, adverse events, glucose monitoring and lab test monitoring on screening and at follow up after 72 hours. Throughout the study blood glucose levels would be monitored to maintain the blood glucose level between 3.3 to 7.7 mmol/liter. Measurements/ Analysis: Insulin and C-peptide through Chemiluminescence. Pharmacokinetic parameters would be determined by model independent method using PPstat soft ware. Ethical consideration: Approved from IRB and full compliance to ICH-GCP.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201203227978N2
Registration date: 2012-04-01, 1391/01/13
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-04-01, 1391/01/13
Registrant information
Name
Tasneem Ahmad
Name of organization / entity
Pharma Professional Services, Karachi, Pakistan
Country
Pakistan
Phone
(92-21) 34972358, 34820573
Email address
tasneem.ahmed@iccs.edu
Recruitment status
Recruitment complete
Funding source
Getz Pharma (Pvt) Ltd; Karachi, Pakistan
Expected recruitment start date
2012-06-22, 1391/04/02
Expected recruitment end date
2012-06-22, 1391/04/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In healthy human volunteers; study ‎of Insulin Glargine (Basagine™) after single ‎subcutaneous injection of 0.2 unit/Kg dose; compared with nothing ‎and primarily to establish the PK parameters Cmax, ‎Tmax and AUC in Pakistani population.‎
Public title
A STUDY OF BASAGINE™ IN LOCAL HEALTHY HUMAN SUBJECTS TO EVALUATE ITS PHARMACOKINETIC BEHAVIOUR
Purpose
Other
Inclusion/Exclusion criteria
INCLUSION: Healthy male/female, Age:18 to 50 years, BMI: 18-26 Kg/m2, Fasting plasma glucose: <6.0 mmol/l (<108 mg/dl) or normal range and Non-smoker, non-alcoholic EXCLUSION: • Volunteers with any neuropathy, diabetes mellitus. • Any active allergic disease or a history of significant allergic disease. • Presence of renal, hepatic or gastrointestinal disease known to interfere with the drug absorption, distribution, metabolism or elimination with in last year. • Subject demonstrates protocol non-compliance (e.g. uncooperative attitude, & inability to finish study). • Participation in another study within last 2 months of 1st drug administration. • If donated blood within last 2 months preceding the study. • Age below 18 years and above 50yr. • Smoking within last 3 months prior to the drug administration and 6 hours after drug administration. • Ingestion of OTC drug (except Paracetamol) within last 14 days of 1st drug administration. • Participants with insufficient organ and/or bone marrow dysfunction. • Ingestion of investigational drug within 1 year prior to 1st drug administration. • Participants with an uncontrolled medical condition (i.e., hypertension, cardiac arrhythmias, CHF) that places the patient at risk by participating in the study. • Results of CBC, LFT, serum creatinine, fasting plasma glucose indicating significantly out of range and abnormal ECG. • Participants with any physical/mental disability • Subjects with known HIV, hepatitis B or hepatitis C infection, or autoimmune diseases. • History of major organ transplantation, new onset diabetes, unstable thyroid function. • Alcohol or drug abuse within the past year. • Known hypersensitivity to investigational drug • Positive drug of abuse test and alcohol test. • Intake of gutka, pan and any other thing containing nicotine 48 hours before and during study.
Age
From 18 years old to 50 years old
Gender
Male
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 14
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Open label, single period, single treatment, and single dose study in fourteen healthy volunteers.

Secondary Ids

1

Registry name
The Universal Trial Number (UTN)
Secondary trial Id
U1111-1129-4410
Registration date
2012-03-24, 1391/01/05

Ethics committees

1

Ethics committee
Name of ethics committee
Institutuional Review Board, Civil Hospital, Dow University of Health Sciences, Karachi
Street address
Institutuional Review Board, Civil Hospital, Dow University of Health Sciences, Karachi
City
Karachi
Postal code
74200
Approval date
2012-03-10, 1390/12/20
Ethics committee reference number
IRB-311/DUHS-12

Health conditions studied

1

Description of health condition studied
Diabetes mellitus
ICD-10 code
E10-E14
ICD-10 code description
Diabetes mellitus Without complications

Primary outcomes

1

Description
Serum levels of Inslin and C-peptide
Timepoint
30 min, 15 min before and 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, 22, 23, 24, 25 hours after
Method of measurement
Serum concentrations of Insulin and C-peptide would be measured through Chemiluminescence.

Secondary outcomes

1

Description
Pharmacokinetic parameters: Cmax, Tmax and AUC0-t
Timepoint
Pharmacokinetic (PK) parameter will be determined: Area under the curve to the last measurable concentration (AUC_ 0-t) will be calculated by the linear trapezoidal rule. C_max and t_max would also be recorded form the drug concentration vs time profile.
Method of measurement
Pharmacokinetic (PK) parameter will be determined on the basis of measurement of exogenous and endogenous concentration of insulin; performed by means of model independent method using PPstat computer programs.

Intervention groups

1

Description
Administration of Insulin-Glargine (rDNA origin; 100 u/ml; Basagine™) 0.2 units/Kg subcutaneous dose
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dow University of Health Sciences (DUHS), Karachi
Full name of responsible person
Dr. Khaqan Ahmad
Street address
Dow University of Health Sciences (DUHS) Ojha Campus
City
Karachi

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Getz Pharma (Pvt) Limited
Full name of responsible person
Dr. Khawar Mehdi
Street address
Director Medical Affairs, 29-30, Secotr-27, Korangi Industrial Area 
City
Karachi
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Getz Pharma (Pvt) Limited
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Pharma Professional Services, Karachi, Pakistan
Full name of responsible person
Ms. Ghousia Saba
Position
Chief Scientific Officer
Other areas of specialty/work
Street address
8 Gulshan View, Gulshan-e-Iqbal, Karachi,
City
Karachi
Province
Sind
Postal code
75300
Phone
00922134972358
Fax
Email
ghousia@phaps.com
Web page address
www.phaps.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Pharma Professional Services, Karachi, Pakistan
Full name of responsible person
Prof. Dr. Tasneem Ahmad
Position
CEO/ B.Pharm, M.Pharm, Ph.D.
Other areas of specialty/work
Street address
8 Gulshan View, Gulshan-e-Iqbal, Karachi,
City
Karachi
Province
Sind
Postal code
75300
Phone
00922134972358
Fax
Email
tasneem_ahmad2001@yahoo.com
Web page address
www.phaps.com

Person responsible for updating data

Contact
Name of organization / entity
Pharma Professional Services, Karachi, Pakistan
Full name of responsible person
Prof. Dr. Tasneem Ahmad
Position
CEO/ B.Pharm, M.Pharm, Ph.D.
Other areas of specialty/work
Street address
8 Gulshan View, Gulshan-e-Iqbal, Karachi,
City
Karachi
Province
Sind
Postal code
75300
Phone
00922134972358
Fax
Email
tasneem_ahmad2001@yahoo.com
Web page address
www.phaps.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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