Type 1 DiabetesPhase 1NCT00239148
A Study in Type 1 Diabetic Patients With Repeated Doses of E1 in Combination With G1
A Phase 1 study testing E1 and G1 in people with Type 1 Diabetes, run by OPKO Health, Inc. at 5 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 1 diabetes. Type 1 diabetes is an autoimmune disease, in which the immune system attacks pancreatic beta cells. These cells produce insulin, which regulates blood glucose. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- E1 and G1
- How many people
- 20 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2005to Dec 2006
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis Type 1 diabetes requiring treatment with insulin for a minimum of 1 year
- On a stable insulin regimen for at least 60 days prior to screening
- Currently self monitoring blood glucose levels at least 3 times per day
- No episodes of severe hypoglycemia for 60 days prior to screening
- Body mass index within the range 19-30 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
- History of hypoglycemia unawareness
- Non-healed diabetic ulcer
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Pinnacle Research Group
Anniston, Alabama, 36207
Diabetes - Endocrinology Center of West New York
Buffalo, New York, 14209
Highgate Specialty Center
Durham, North Carolina, 27713
Diabetes and Glandular Disease Research Associates
San Antonio, Texas, 78229-4801
Diablo Clinical Research
Walnut Creek, California, 94598
About this study
Official title: A Randomized, Double-blind, Controlled Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Effects of Repeated Subcutaneous Doses of E1 in Combination With G1 in Type 1 Diabetes
The purpose of the study is to determine whether E1 and G1 are safe and effective in the treatment of type 1 diabetes.
Type 1 diabetes is an autoimmune disease, in which the immune system attacks pancreatic beta cells. These cells produce insulin, which regulates blood glucose. The mainstay of current treatment for type 1 diabetes is dietary control and daily parenteral administration of insulin.
Recent diabetes 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 pancreatic insulin production in diabetic animal models. It is therefore postulated that treatment with E1 and G1 may produce islet cell regeneration in type 1 diabetic patients.
Read the detailed description
In this study, 20 type 1 diabetic patients requiring insulin therapy will be randomized. Fifteen (15) patients will be randomized to receive active study medication and 5 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 insulin regimen and will maintain a diary record of insulin intake and blood glucose levels.
Pancreatic beta cell function or insulin secretion is best measured by determination of c-peptide (which is co-secreted with insulin in a 1:1 ratio). An arginine stimulated c-peptide test will therefore be performed at frequent intervals during the study. Patients will be injected with a solution containing arginine, a normal constituent of food that increases insulin release from beta cells into the blood. After the injection seven blood samples for c-peptide tests will be collected over 10 minutes.
- Conditions
- Type 1 Diabetes
- Being tested
- E1 and G1
- Keywords
- Type 1 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1
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 evaluate the safety and tolerability of repeated subcutaneous doses of E1 in combination with G1 in patients with type 1 diabetes
Secondary outcomes (1)
To evaluate the pharmacokinetic (PK) profile and clinical effects of repeated subcutaneous doses of E1 in combination with G1 in patients with type 1 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 startJun 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 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
- 20 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
- NCT00239148
- Sponsor's protocol ID
- INT-201
- 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, Controlled Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Effects of Repeated Subcutaneous Doses of E1 in Combination With G1 in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00239148
- Acronym / sponsor ID
- INT-201
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2005
- Study completion
- Dec 2006 (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 1 diabetes.
Type 1 diabetes is an autoimmune disease, in which the immune system attacks pancreatic beta cells. These cells produce insulin, which regulates blood glucose. The mainstay of current treatment for type 1 diabetes is dietary control and daily parenteral administration of insulin.
Recent diabetes 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 pancreatic insulin production in diabetic animal models. It is therefore postulated that treatment with E1 and G1 may produce islet cell regeneration in type 1 diabetic patients.
Detailed description
In this study, 20 type 1 diabetic patients requiring insulin therapy will be randomized. Fifteen (15) patients will be randomized to receive active study medication and 5 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 insulin regimen and will maintain a diary record of insulin intake and blood glucose levels.
Pancreatic beta cell function or insulin secretion is best measured by determination of c-peptide (which is co-secreted with insulin in a 1:1 ratio). An arginine stimulated c-peptide test will therefore be performed at frequent intervals during the study. Patients will be injected with a solution containing arginine, a normal constituent of food that increases insulin release from beta cells into the blood. After the injection seven blood samples for c-peptide tests will be collected over 10 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Clinical diagnosis Type 1 diabetes requiring treatment with insulin for a minimum of 1 year
- On a stable insulin regimen for at least 60 days prior to screening
- Currently self monitoring blood glucose levels at least 3 times per day
- No episodes of severe hypoglycemia for 60 days prior to screening
- Body mass index within the range 19-30 kg/m2
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 evaluate the safety and tolerability of repeated subcutaneous doses of E1 in combination with G1 in patients with type 1 diabetes
1 secondary outcome
To evaluate the pharmacokinetic (PK) profile and clinical effects of repeated subcutaneous doses of E1 in combination with G1 in patients with type 1 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.
Related trials for Type 1 Diabetes
Active, not recruitingPhase 3
Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes
Diabetes Mellitus, Type 1
Recruiting
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
Diabetic Foot Disease, Diabetic Foot Infection
Not yet recruiting
Safety and Efficacy of the Fully Closed Loop iLet Bionic Pancreas in Adults With Type 1 and Type 2 Diabetes
Diabetes (Insulin-requiring, Type 1 or Type 2)
Active, not recruitingPhase 2
Probiotics in Newly Diagnosed T1D
Type 1 Diabetes, Type1diabetes
Active, not recruitingPhase 2
Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults and Adolescents on Top of Insulin Therapy (FABULINUS)
Type 1 Diabetes Mellitus
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.
5 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 1 Diabetes, run by OPKO Health, Inc. at 5 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 6 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 5 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 evaluate the safety and tolerability of repeated subcutaneous doses of E1 in combination with G1 in patients with type 1 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.