Type 2 DiabetesPhase 1NCT00239187
A Study in Type 2 Diabetic Patients With Repeated Doses of E1 in Combination With G1
A Phase 1 study testing E1 and G1 in people with Type 2 Diabetes, run by OPKO Health, Inc. at 3 sites in United States.
Trial summary
The purpose of the study is to determine whether E1 and G1 are safe and effective in the treatment of type 2 diabetes. Type 2 diabetes is the most common form of diabetes. The disease is characterised by insulin resistance and a compensated state of hyperinsulinemia. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- E1 and G1
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2005to Jan 2007
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Informed consent obtained from participants
- Clinical diagnosis Type 2 diabetes requiring treatment with Metformin and/or TZD and who are otherwise healthy
- On a stable Metformin and/or TZD regimen for at least 60 days prior to screening
- Maximum stimulated c-peptide level > 0.6 nmol/L (1.8 ng/mL)
- Currently self monitoring blood glucose levels (i.e. daily)
- No episodes of severe hypoglycemia for 60 days prior to screening
- Body mass index within the range 25-40 kg/m2
- Patient cannot live alone during the treatment phase and up to 1 month in follow-up
Who cannot join
- Known of suspected history of significant liver, or other GI disease
- History of significant cardiovascular disease including stroke, peripheral vascular disease or any related symptoms
- History of peptic ulcer disease and/or GI bleeding/perforation
- History of cancer
- History or presence of proliferative retinopathy, severe non-proliferative retinopathy, macular edema or presence of untreated diabetic eye disease
- History of treated peripheral or autonomic neuropathy
Show all 9Show fewer
- Serum creatine superior or equal to 2.0 mg/dL
- Non-healed diabetic ulcer
- History of hypoglycemic unawareness
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Profil Institute for Clinical Research Inc.
Chula Vista, California, 91911
Clinical Research of West Florida
Clearwater, Florida, 33765-2616
Diabetes and Glandular Disease Research Associates
San Antonio, Texas, 78229-4801
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Response of Repeated Subcutaneous Doses of E1 in Combination With G1 in Patients With Type 2 Diabetes
The purpose of the study is to determine whether E1 and G1 are safe and effective in the treatment of type 2 diabetes.
Type 2 diabetes is the most common form of diabetes. The disease is characterised by insulin resistance and a compensated state of hyperinsulinemia. In most individual, hyperglycemia results from a failure of pancreatic beta cells insulin secretory capacity to adequately compensate for insulin resistance in peripheral tissues. Treatment for type 2 diabetes is achieved by dietary control, or a combination of diet and oral hypoglycemic agents or insulin. As the disease progress, many type 2 diabetic patients eventually require insulin as primary therapy to achieve glycemic control.
Recent diabetic research has increasingly focused on pancreatic islet cell replacement, either by islet cell transplantation or by endogenous regeneration of islet cells. During fetal development, islet precursor cells proliferate and differentiate into mature beta cells capable of producing insulin. This process is known as islet cell neogenesis. Islet cell neogenesis normally ceases around birth, however, the adult pancreas still retains significant potential for islet regeneration, as shown by tissue repair following pancreatic injury. Pre-clinical studies have shown that E1 and G1 can re-establish islet cell neogenesis and increase insulin production in diabetic animal models. In type 2 diabetic patients, treatment with E1 and G1 may result in islet cell regeneration. This therapeutic approach may improve beta cell function, restore the loss of insulin secretory capacity and also benefit patients on oral hypoglycemic agents by delaying insulin use.
Read the detailed description
In this study, 30 type 2 diabetic patients requiring oral hypoglycemic therapy with Metformin and/or Thiazolidinedione will be randomized. Twenty (20) patients will be randomized to receive active study medication and 10 patients will be randomized to receive vehicle control. After undergoing screening procedures, potential patients will enter a 14 day baseline phase where baseline data will be collected. Pending successful completion of the baseline phase, patient will enter a 28-day treatment phase where they will be randomized to receive either once daily subcutaneous injections of E1 plus G1, as separate injections or once daily subcutaneous injections of vehicle control (as 2 separate injections). Patients will receive once daily doses in the morning after breakfast for a period of 28 days. Upon completion of treatment, all patients will continue in the follow-up phase for an additional 6 months and will return to the clinic for monthly visits. Throughout the study, patients will remain on their current oral hypoglycemic therapy with Metformin and/or Thiazolidinedione and will maintain a diary record of blood glucose levels.
The body's ability to control glucose will be assessed by oral glucose tolerance test (OGTT). After an overnight fast, patients will be asked to drink a solution containing a known amount of glucose. Blood samples for glucose and insulin measurements will be obtained before the patients drink the glucose solution, and again 30 minutes, 60 minutes and 2 hours after the glucose is consumed. This test will be performed at frequent intervals during the study.
- Conditions
- Type 2 Diabetes
- Being tested
- E1 and G1
- Keywords
- Type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E1 and G1Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of repeated subcutaneous doses of E1 in combination with G1 in patients with type 2 diabetes
Secondary outcomes (1)
To evaluate the pharmacokinetics (PK) profile and clinical effects of repeated subcutaneous doses of E1 in combination with G1 in patients with type 2 diabetes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2005 (estimated)
- Study startSep 2005
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- OPKO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Aleksandra Pastrak, M.D., Study director, OPKO Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239187
- Sponsor's protocol ID
- INT-202
- Status last verified
- Oct 2019
- First submitted
- 12 Oct 2005
- Last updated
- 18 Oct 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Response of Repeated Subcutaneous Doses of E1 in Combination With G1 in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00239187
- Acronym / sponsor ID
- INT-202
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2005
- Study completion
- Jan 2007 (actual)
- First posted
- 14 Oct 2005 (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.
The purpose of the study is to determine whether E1 and G1 are safe and effective in the treatment of type 2 diabetes.
Type 2 diabetes is the most common form of diabetes. The disease is characterised by insulin resistance and a compensated state of hyperinsulinemia. In most individual, hyperglycemia results from a failure of pancreatic beta cells insulin secretory capacity to adequately compensate for insulin resistance in peripheral tissues. Treatment for type 2 diabetes is achieved by dietary control, or a combination of diet and oral hypoglycemic agents or insulin. As the disease progress, many type 2 diabetic patients eventually require insulin as primary therapy to achieve glycemic control.
Recent diabetic research has increasingly focused on pancreatic islet cell replacement, either by islet cell transplantation or by endogenous regeneration of islet cells. During fetal development, islet precursor cells proliferate and differentiate into mature beta cells capable of producing insulin. This process is known as islet cell neogenesis. Islet cell neogenesis normally ceases around birth, however, the adult pancreas still retains significant potential for islet regeneration, as shown by tissue repair following pancreatic injury. Pre-clinical studies have shown that E1 and G1 can re-establish islet cell neogenesis and increase insulin production in diabetic animal models. In type 2 diabetic patients, treatment with E1 and G1 may result in islet cell regeneration. This therapeutic approach may improve beta cell function, restore the loss of insulin secretory capacity and also benefit patients on oral hypoglycemic agents by delaying insulin use.
Detailed description
In this study, 30 type 2 diabetic patients requiring oral hypoglycemic therapy with Metformin and/or Thiazolidinedione will be randomized. Twenty (20) patients will be randomized to receive active study medication and 10 patients will be randomized to receive vehicle control. After undergoing screening procedures, potential patients will enter a 14 day baseline phase where baseline data will be collected. Pending successful completion of the baseline phase, patient will enter a 28-day treatment phase where they will be randomized to receive either once daily subcutaneous injections of E1 plus G1, as separate injections or once daily subcutaneous injections of vehicle control (as 2 separate injections). Patients will receive once daily doses in the morning after breakfast for a period of 28 days. Upon completion of treatment, all patients will continue in the follow-up phase for an additional 6 months and will return to the clinic for monthly visits. Throughout the study, patients will remain on their current oral hypoglycemic therapy with Metformin and/or Thiazolidinedione and will maintain a diary record of blood glucose levels.
The body's ability to control glucose will be assessed by oral glucose tolerance test (OGTT). After an overnight fast, patients will be asked to drink a solution containing a known amount of glucose. Blood samples for glucose and insulin measurements will be obtained before the patients drink the glucose solution, and again 30 minutes, 60 minutes and 2 hours after the glucose is consumed. This test will be performed at frequent intervals during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Informed consent obtained from participants
- Clinical diagnosis Type 2 diabetes requiring treatment with Metformin and/or TZD and who are otherwise healthy
- On a stable Metformin and/or TZD regimen for at least 60 days prior to screening
- Maximum stimulated c-peptide level > 0.6 nmol/L (1.8 ng/mL)
- Currently self monitoring blood glucose levels (i.e. daily)
Key exclusion criteria (9 listed)
- Known of suspected history of significant liver, or other GI disease
- History of significant cardiovascular disease including stroke, peripheral vascular disease or any related symptoms
- History of peptic ulcer disease and/or GI bleeding/perforation
- History of cancer
- History or presence of proliferative retinopathy, severe non-proliferative retinopathy, macular edema or presence of untreated diabetic eye disease
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 |
|---|---|---|
| E1 and G1 | Drug | – |
Primary outcome
To assess the safety and tolerability of repeated subcutaneous doses of E1 in combination with G1 in patients with type 2 diabetes
1 secondary outcome
To evaluate the pharmacokinetics (PK) profile and clinical effects of repeated subcutaneous doses of E1 in combination with G1 in patients with type 2 diabetes
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 18 Oct 2019.
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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.
Aleksandra Pastrak, M.D. study director
OPKO Health, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E1 and G1 in people with Type 2 Diabetes, run by OPKO Health, Inc. at 3 sites 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 8 inclusion and 9 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 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
To assess the safety and tolerability of repeated subcutaneous doses of E1 in combination with G1 in patients with type 2 diabetes. 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 18 Oct 2019.