Diabetes Mellitus, Type 2Phase 1NCT03686722
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
A Phase 1 study testing Metformin and Daclatasvir in people with Diabetes Mellitus, Type 2 and Hepatitis C, run by Mohamed Raslan at 1 site in Egypt.
Trial summary
A Randomized,Two-period, Crossover Study to Determine the Possibility of Drug-drug Interaction After Co-administration of Metformin and Daclatasvir Where Twenty Eligible Adult Subjects Will be Randomized to Receive Either Metformin Only and/or Metformin Co-administered With Daclatasvir to measure primary outcomes… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hepatitis C, Drug Interactions
- What is being tested?
- Metformin and Daclatasvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Sep 2017to 6 Dec 2017
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is at least 18-55 years at screening.
- Subject has a Body Mass Index of 18 to 35 kg/m2.
- Subject are non smokers or moderate smokers(not more than 10 cigarettes per day)
- Subjects is willing to participate and give their final written consent prior to the commencement of the study procedures
- Subject is in good age-appropriate health condition as established by medical history, physical examination, and results of biochemistry, hematology and urine analysis testing within 4 weeks prior to study.
- Subject has a normal blood pressure and pulse rate, according to the reference normal ranges.
Who cannot join
- Treatment with any known enzyme-inducing/inhibiting agents prior to the start of the study and throughout the study.
- Subjects who have taken any medication two weeks preceding of the trial starting date.
- Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
- Any prior surgery of the gastrointestinal tract that may interfere with drug absorption.
- Gastrointestinal diseases.
- Renal diseases.
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- Cardiovascular diseases specially transient ischemic attacks and cardiac dysrhythmia .
- Pancreatic disease including diabetes.
- Hepatic diseases as hepatic failure, cirrhosis, galactose intolerance, fructose intolerance, glycogen storage diseases
- Hematological disease or pulmonary disease
- Abnormal laboratory values.
- Subjects who have donated blood or who have been involved in a drug study within 6 weeks preceding the start of the study.
- Positive HIV test.
- History of or current abuse of drugs, alcohol or solvents.
- Endocrine disorders as Pheochromocytoma, Addison disease, glucagon deficiency, carcinomas, extrahepatic tumors
- Autoimmune disorders as Graves disease
- Central nervous system (CNS) disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetics and Pharmacodynamics of Metformin
A Randomized,Two-period, Crossover Study to Determine the Possibility of Drug-drug Interaction After Co-administration of Metformin and Daclatasvir Where Twenty Eligible Adult Subjects Will be Randomized to Receive Either Metformin Only and/or Metformin Co-administered With Daclatasvir to measure primary outcomes including pharmacokinetics parameters as: Maximum drug concentration in plasma(Cmax), Area under the Plasma concentration Versus Time Curve from time 0 to 12 hours(AUC0-12), Clearance(CL)
Read the detailed description
Study Design:
A randomized, one-way, single blinded, two-period, crossover study in adult human healthy egyptian volunteers
Methodology:
period (I): Group A:10 volunteers will receive 500 mg Metformin twice daily on day 1-4 then 1000mg metformin twice on day 5-7
GroupB:10 volunteers will receive 500 mg Metformin twice daily + Daclatasvir (DCV) 60 mg once daily on day 1-4 then 1000mg metformin twice daily+DCV 60 mg once daily on day 5-7
period (II): Group A:10 volunteers will receive 500 mg Metformin twice daily + Daclatasvir (DCV) 60 mg once daily on day 1-4 then 1000mg metformin twice daily+DCV 60 mg once daily on day 5-7
Group B:10 volunteers will receive 500 mg Metformin twice daily on day 1-4 then 1000mg metformin twice daily on day 5-7
All drug administration will be followed by 240 ml of water after at least 10 hours fasting prior to administration.
The two treatment periods will be separated by a one week washout period
Blood Sampling will be collected at a pre-dosing and at 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12 hours Urine samples will be collected for metformin analysis from 0 to 12 hours after drug administration.
A 75 g Oral glucose tolerance test(OGTT) will be carried out by ingestion of 75g glucose in 240ml water 2-hours post dosing and blood samples for determining glucose concentration during OGTTs were collected immediately before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, and 3 hours after glucose ingestion.
Blood samples will be collected from each volunteer prior to drug administration (blank) at the predetermined sampling intervals after drug administration in ethylene diamine tetra-acetic acid(kEDTA) containing tubes.
These samples will be centrifuged and the plasma harvested and stored at -80°C until assay.
- Conditions
- Diabetes Mellitus, Type 2, Hepatitis C, Drug Interactions
- Being tested
- Metformin, Daclatasvir
- Medical subject headings
- Diabetes Mellitus, Type 2, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Metformin is used primarly in treatment of diabetes type II
DaclatasvirDrug
Daclatsvir is a direct acting antiviral drug
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | Subjects administered Metformin 500mg(Glucophage tablets) twice daily till day(4) then Metformin 1000mg twice daily till day(7) Receives: Drug: Metformin |
| Metformin and Daclatasvir | Experimental | Subjects Coadministered Metformin 500mg(Glucophage tablets) twice daily and Daclatasvir 60mg tablets once daily till day (4) then Metformin 1000mg twice daily and Daclatasvir 60mg tablets once daily till Day(7) Receives: Drug: Metformin; Drug: Daclatasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
(AUC0→12)
Area under the plasma concentration-time curve measured in (nanogram(ng).hr/ml)
Measured: From first sampling interval(time zero) up to 12 hours
Area under the plasma concentration-time curve from time 0 to infinity (AUC0→∞)
Area under the plasma concentration-time curve from time 0 to infinity measured in(ng.hr/ml)
Measured: From first sampling interval up to infinity
Area under the plasma concentration-time curve from time 0 to tau(AUC0→tau)
Area under the plasma concentration-time curve from time 0 to tau measured in(ng.hr/ml)
Measured: From first sampling interval up to dosing interval(Tau)
Maximum drug concentration in plasma at steady state(Cpss)
Maximum drug concentration in plasma at steady state measured in (ng/ml)
Measured: Time corresponding to maximum drug concentration in plasma at steady state
Half life( t½) of drug in plasma
Half life of drug measured in Hours(hr)
Measured: Up to 12 hours
Mean residence time of drug(MRT)
Mean residence time of drug in plasma measured in (hr)
Measured: From first sampling interval up to 12 hours
steady state Clearance of drug(CLss)
steady state Clearance of drug measured in (ml/min)
Measured: From first sampling interval up to 12 hours
Renal Clearance of drug(CLr)
Renal Clearance of drug measured in (ml/min)
Measured: From first sampling interval up to 12 hours
Cumulative amount of drug eliminated in urine (Ae)
Cumulative amount of drug eliminated in urine measured in (microgram(ug)/ml)
Measured: From first sampling interval up to 12 hours
Maximum excretion rate (Urate max)
Maximum excretion rate for the drug measured in (milligram(mg)/hr)
Measured: From first sampling interval up to 12 hours
Secondary outcomes (3)
Blood Glucose(BG) levels
Blood glucose levels measured in (mg/dl)
Measured: up to 3 hours
Area under the BG-time curve(AUG)0-3hr
Area under the BG-time curve measured in (mg.hr/dl)
Measured: up to 3 hours
Maximum Glucose concentration(Gmax)
Maximum Glucose concentration measured in (mg/dl)
Measured: up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start9 Sep 2017
- Primary completion30 Oct 2017
- Study completion6 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Twenty Eligible Adult Subjects Will be Randomized Equally into two Groups: A and B To Receive Either: Group (A):10 subjects will receive 500 mg Metformin twice daily on day 1-4 then 1000mg metformin twice on day 5-7 Group (B):10 subjects will receive 500 mg co-administered daily with Daclatasvir 60 mg once daily on day 1-4 then 1000mg Metformin co-administered twice daily with Daclatasvir 60 mg once daily on day 5-7
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Raslan
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University, Drug Research Centre, Cairo, Egypt
- Responsible party
- Sponsor-investigator, Mohamed Raslan, Ain Shams University
- Investigators
- Mohamed Raslan, Principal investigator, Ainshams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686722
- Sponsor's protocol ID
- MET-DAC\DDIS\01217
- Status last verified
- Oct 2018
- First submitted
- 23 Sep 2018
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetics and Pharmacodynamics of Metformin
- ClinicalTrials.gov ID
- NCT03686722
- Acronym / sponsor ID
- MET-DAC\DDIS\01217
- Conditions
- Diabetes Mellitus, Type 2, Hepatitis C, Drug Interactions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mohamed RaslanUniversity, hospital or other
- Collaborators
- Ain Shams University, Drug Research Centre, Cairo, Egypt
- Study start
- 9 Sep 2017 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 6 Dec 2017 (actual)
- First posted
- 27 Sep 2018 (actual)
- 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.
A Randomized,Two-period, Crossover Study to Determine the Possibility of Drug-drug Interaction After Co-administration of Metformin and Daclatasvir Where Twenty Eligible Adult Subjects Will be Randomized to Receive Either Metformin Only and/or Metformin Co-administered With Daclatasvir to measure primary outcomes including pharmacokinetics parameters as: Maximum drug concentration in plasma(Cmax), Area under the Plasma concentration Versus Time Curve from time 0 to 12 hours(AUC0-12), Clearance(CL)
Detailed description
Study Design:
A randomized, one-way, single blinded, two-period, crossover study in adult human healthy egyptian volunteers
Methodology:
period (I): Group A:10 volunteers will receive 500 mg Metformin twice daily on day 1-4 then 1000mg metformin twice on day 5-7
GroupB:10 volunteers will receive 500 mg Metformin twice daily + Daclatasvir (DCV) 60 mg once daily on day 1-4 then 1000mg metformin twice daily+DCV 60 mg once daily on day 5-7
period (II): Group A:10 volunteers will receive 500 mg Metformin twice daily + Daclatasvir (DCV) 60 mg once daily on day 1-4 then 1000mg metformin twice daily+DCV 60 mg once daily on day 5-7
Group B:10 volunteers will receive 500 mg Metformin twice daily on day 1-4 then 1000mg metformin twice daily on day 5-7
All drug administration will be followed by 240 ml of water after at least 10 hours fasting prior to administration.
The two treatment periods will be separated by a one week washout period
Blood Sampling will be collected at a pre-dosing and at 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12 hours Urine samples will be collected for metformin analysis from 0 to 12 hours after drug administration.
A 75 g Oral glucose tolerance test(OGTT) will be carried out by ingestion of 75g glucose in 240ml water 2-hours post dosing and blood samples for determining glucose concentration during OGTTs were collected immediately before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, and 3 hours after glucose ingestion.
Blood samples will be collected from each volunteer prior to drug administration (blank) at the predetermined sampling intervals after drug administration in ethylene diamine tetra-acetic acid(kEDTA) containing tubes.
These samples will be centrifuged and the plasma harvested and stored at -80°C until assay.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Twenty Eligible Adult Subjects Will be Randomized Equally into two Groups: A and B To Receive Either: Group (A):10 subjects will receive 500 mg Metformin twice daily on day 1-4 then 1000mg metformin twice on day 5-7 Group (B):10 subjects will receive 500 mg co-administered daily with Daclatasvir 60 mg once daily on day 1-4 then 1000mg Metformin co-administered twice daily with Daclatasvir 60 mg once daily on day 5-7
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: MetforminSubjects administered Metformin 500mg(Glucophage tablets) twice daily till day(4) then Metformin 1000mg twice daily till day(7) |
| Metformin and Daclatasvir | Experimental | Drug: Metformin, Drug: DaclatasvirSubjects Coadministered Metformin 500mg(Glucophage tablets) twice daily and Daclatasvir 60mg tablets once daily till day (4) then Metformin 1000mg twice daily and Daclatasvir 60mg tablets once daily till Day(7) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject is at least 18-55 years at screening.
- Subject has a Body Mass Index of 18 to 35 kg/m2.
- Subject are non smokers or moderate smokers(not more than 10 cigarettes per day)
- Subjects is willing to participate and give their final written consent prior to the commencement of the study procedures
- Subject is in good age-appropriate health condition as established by medical history, physical examination, and results of biochemistry, hematology and urine analysis testing within 4 weeks prior to study.
Key exclusion criteria (17 listed)
- Treatment with any known enzyme-inducing/inhibiting agents prior to the start of the study and throughout the study.
- Subjects who have taken any medication two weeks preceding of the trial starting date.
- Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
- Any prior surgery of the gastrointestinal tract that may interfere with drug absorption.
- Gastrointestinal diseases.
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 |
|---|---|---|
| MetforminMetformin is used primarly in treatment of diabetes type II | Drug | Metformin, Metformin and Daclatasvir |
| DaclatasvirDaclatsvir is a direct acting antiviral drug | Drug | Metformin and Daclatasvir |
Primary outcome
(AUC0→12)
Time frame: From first sampling interval(time zero) up to 12 hours
Area under the plasma concentration-time curve measured in (nanogram(ng).hr/ml)
Area under the plasma concentration-time curve from time 0 to infinity (AUC0→∞)
Time frame: From first sampling interval up to infinity
Area under the plasma concentration-time curve from time 0 to infinity measured in(ng.hr/ml)
Area under the plasma concentration-time curve from time 0 to tau(AUC0→tau)
Time frame: From first sampling interval up to dosing interval(Tau)
Area under the plasma concentration-time curve from time 0 to tau measured in(ng.hr/ml)
Maximum drug concentration in plasma at steady state(Cpss)
Time frame: Time corresponding to maximum drug concentration in plasma at steady state
Maximum drug concentration in plasma at steady state measured in (ng/ml)
Half life( t½) of drug in plasma
Time frame: Up to 12 hours
Half life of drug measured in Hours(hr)
Mean residence time of drug(MRT)
Time frame: From first sampling interval up to 12 hours
Mean residence time of drug in plasma measured in (hr)
steady state Clearance of drug(CLss)
Time frame: From first sampling interval up to 12 hours
steady state Clearance of drug measured in (ml/min)
Renal Clearance of drug(CLr)
Time frame: From first sampling interval up to 12 hours
Renal Clearance of drug measured in (ml/min)
Cumulative amount of drug eliminated in urine (Ae)
Time frame: From first sampling interval up to 12 hours
Cumulative amount of drug eliminated in urine measured in (microgram(ug)/ml)
Maximum excretion rate (Urate max)
Time frame: From first sampling interval up to 12 hours
Maximum excretion rate for the drug measured in (milligram(mg)/hr)
3 secondary outcomes
Blood Glucose(BG) levels
Time frame: up to 3 hours
Area under the BG-time curve(AUG)0-3hr
Time frame: up to 3 hours
Maximum Glucose concentration(Gmax)
Time frame: up to 3 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 12 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Mohamed Raslan principal investigator
Ainshams university
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 Metformin and Daclatasvir in people with Diabetes Mellitus, Type 2 and Hepatitis C, run by Mohamed Raslan at 1 site in Egypt.
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 6 inclusion and 17 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 12 Oct 2018. 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 Egypt. 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?
(AUC0→12) (time frame: From first sampling interval(time zero) up to 12 hours). The study lists 10 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 12 Oct 2018.