DiabetesPhase 2/3NCT00814294

Study of Two Doses of Oral HDV-Insulin and Placebo With Background Metformin Treatment in Patients With Type 2 Diabetes Mellitus

A Phase 2/3 study testing Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15) and Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5) in people with Diabetes, run by Diasome Pharmaceuticals at 40 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this trial is to compare the reduction in mean glycated hemoglobin levels (HbA1c) between 2 doses of oral HDV-I and placebo in type 2 diabetic patients on background metformin therapy at the end of 18 weeks of treatment. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Diabetes
What is being tested?: Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15) and Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 239 participants
Where: 40 sitesUnited States
Study dates: Dec 2008to Sep 2009
Phase: Phase 2/3
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 to 70 years, inclusive;
Diagnosis of type 2 diabetes mellitus;
Fasting plasma glucose <=250 mg/dL;
BMI <=45 kg/m2;
HbA1c levels as follows at Screening:
On a stable dose of metformin monotherapy with an HbA1c >=7.5% and <=9.5%;

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On metformin and 1 other OAD (excluding TZD, exenatide, or insulin) with an HbA1c >=6.8% and <=9.0%;
Naïve to antidiabetic therapy or have not been on a stable dose of metformin monotherapy for <12 weeks with an HbA1c >=8.0% and <=10.5%;
Understanding of the study procedures and agreement to participate in the study, giving written informed consent;
Women may be enrolled if all of the following criteria (in addition to the above criteria) are met:
They are not pregnant (women of childbearing potential must have a negative serum pregnancy test at Visit 1);
They are not breast-feeding;
They do not plan to become pregnant during the study; and
They have had a hysterectomy or tubal ligation 6 months prior to the study, have been post-menopausal for 1 year, or will practice a method of birth control throughout the study.

Who cannot join

History of type 1 diabetes and/or history of ketoacidosis;
History of chronic (>2 months) use of insulin therapy or recent initiation of insulin use intended for chronic administration;
Use of TZD (pioglitazone or rosiglitazone) or exenatide within 3 months prior to Screening;
Use of prescription or over the counter weight loss agents within 1 month prior to Screening;
Use of any lipid-altering, antihypertensive, and other chronic use medication not stable for 1 month prior to Screening;
Use of any medication that may alter blood glucose analyses;

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Any serious disorder including cardiac, pulmonary, hepatic, uncontrolled endocrine/metabolic, hematologic/oncologic (within the last 5 years), neurologic, and psychiatric diseases that would interfere with the conduct of the study or interpretation of the data;
Require regular use of medication that interferes with the oral absorption and/or metabolism of insulin or metformin;
History of pancreatitis;
History of acquired immune deficiency syndrome or human immunodeficiency virus;
History of drug or alcohol abuse within the past 2 years;
Hospitalization for any cause within 14 days prior to the study;
History of an allergic or toxic response to oral HDV-I;
Uncontrolled hypertension: systolic blood pressure >160 mmHg and diastolic blood pressure >95 mmHg;
Triglycerides >400 mg/dL;
Aspartate aminotransferase or alanine aminotransferase >2.5 times the upper limit of normal (ULN);
Creatine phosphokinase >3 times the ULN;
Patients on a weight loss program with ongoing weight loss, or starting an intensive exercise program within 4 weeks of starting the study;
Use of any investigational drug within 30 days preceding the first dose of study medication; or
Employment by the research center.

Trial locations and contacts

40 sites in 1 country.

City, postcode or hospital

40 sites in 1 country

United States40 sites

Study site
Atlanta, Georgia, 30308
Study site
Atlanta, Georgia, 30322
Study site
Beaver, Pennsylvania, 15009
Study site
Brockton, Massachusetts, 02301
Study site
Chiefland, Florida, 32626
Study site
Cincinnati, Ohio, 45236
Study site
Concord, California, 94520
Study site
Corpus Christi, Texas, 78404
Study site
Delaware, Ohio, 43015
Study site
El Paso, Texas, 79935
Study site
Fort Lauderdale, Florida, 33308
Study site
Houston, Texas, 77074
Study site
Hurst, Texas, 76054
Study site
Kingsport, Tennessee, 37660
Study site
Lexington, Kentucky, 40504
Study site
Litchfield Park, Arizona, 85340
Study site
Manassas, Virginia, 20110
Study site
Milwaukee, Wisconsin, 53209
Study site
Muscle Shoals, Alabama, 35661
Study site
Odessa, Texas, 79761
Study site
Omaha, Nebraska, 68114
Study site
Paducah, Kentucky, 42003
Study site
Palm Harbor, Florida, 34684
Study site
Paramount, California, 90723
Study site
Pembroke Pines, Florida, 33029
Study site
Picayune, Mississippi, 39466
Study site
Renton, Washington, 98055
Study site
Sacramento, California, 95825
Study site
Salt Lake City, Utah, 84124
Study site
San Antonio, Texas, 78229
Study site
San Antonio, Texas, 78237
Study site
San Mateo, California, 94401
Study site
Staten Island, New York, 10301
Study site
Stockton, California, 95204
Study site
Topeka, Kansas, 66606
Study site
Tucson, Arizona, 85712
Study site
Valley Village, California, 91607
Study site
Virginia Beach, Virginia, 23454
Study site
Walnut Creek, California, 94598
Study site
Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: An 18-Week Randomized, Double-Blind, Multicenter, Comparator Study of Two Doses of Oral HDV-Insulin and Placebo With Background Metformin Treatment in Patients With Type 2 Diabetes Mellitus

The secondary objectives are:

To evaluate the effects of oral HDV-I versus placebo on the 7-point glucose test, fasting plasma glucose (FPG), insulin, homeostasis model assessment of insulin resistance (HOMA-IR), homeostasis model assessment of β-cell function (HOMA-β), frequency of hypoglycemic events, body weight, and lipid levels; and
To evaluate the safety and tolerability of oral HDV-I.

Read the detailed description

This is a multicenter, randomized, double-blind, placebo-controlled study with a washout/stabilization period of up to 12 weeks in duration and an 18-week double-blind treatment period. There will be a total of 8 visits.

Conditions: Diabetes
Being tested: placebo, Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15), Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)
Keywords: Type 2
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

placeboDrug
placebo capsule,0 units, quater in die (QID) for 18 weeks
Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)Drug
Oral HDV-I Caps; 15 U; quater in die (QID) for 18 weeks.
Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)Drug
Oral HDV-I; Caps; 5 U; quater in die (QID) for 18 weeks.

Study groups in NCT00814294
Study group	Role	What they receive
1; Placebo	Placebo comparator	Patients receive a sugar pill. Receives: Drug: placebo
2; Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)	Experimental	Patients receive Oral HDV-Insulin (U-5). Receives: Drug: Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)
3; Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)	Experimental	Patients receive Oral HDV-Insulin (U-15). Receives: Drug: Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)

What is being measured

The primary outcome is the main question the study is designed to answer.

The primary objective of this trial is to compare the reduction in mean glycated hemoglobin levels (HbA1c) between 2 doses of oral HDV-I and placebo in type 2 diabetic patients on background metformin therapy at the end of 18 weeks of treatment.
Measured: 18 weeks

Secondary outcomes (4)

To evaluate the effects of oral HDV-I versus placebo on the 7-point glucose test
Measured: 18 weeks
To evaluate the effects of oral HDV-I versus placebo on fasting plasma glucose (FPG) and insulin
Measured: 18 weeks
To evaluate the effects of oral HDV-I versus placebo on the homeostasis model assessment of insulin resistance (HOMA-IR)and homeostasis model assessment of β-cell function (HOMA-β)
Measured: 18 Weeks
To evaluate the effects of oral HDV-I versus placebo on frequency of hypoglycemic events, body weight, and lipid levels
Measured: 18 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008Sep 2009

First posted24 Dec 2008 (estimated)
Study startDec 2008
Primary completionSep 2009
Study completionSep 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 239 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00814294
Sponsor's protocol ID: DP 01-2007-03
Status last verified: May 2021
First submitted: 23 Dec 2008
Last updated: 26 May 2021
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An 18-Week Randomized, Double-Blind, Multicenter, Comparator Study of Two Doses of Oral HDV-Insulin and Placebo With Background Metformin Treatment in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT00814294
Acronym / sponsor ID: DP 01-2007-03
Conditions: Diabetes
Keywords: Type 2
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 239 participants (actual)
Lead sponsor: Diasome PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 24 Dec 2008 (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 secondary objectives are:

To evaluate the effects of oral HDV-I versus placebo on the 7-point glucose test, fasting plasma glucose (FPG), insulin, homeostasis model assessment of insulin resistance (HOMA-IR), homeostasis model assessment of β-cell function (HOMA-β), frequency of hypoglycemic events, body weight, and lipid levels; and
To evaluate the safety and tolerability of oral HDV-I.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
1; Placebo	Placebo comparator	Drug: placeboPatients receive a sugar pill.
2; Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)	Experimental	Drug: Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)Patients receive Oral HDV-Insulin (U-5).
3; Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)	Experimental	Drug: Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)Patients receive Oral HDV-Insulin (U-15).

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Age 18 to 70 years, inclusive;
Diagnosis of type 2 diabetes mellitus;
Fasting plasma glucose <=250 mg/dL;
BMI <=45 kg/m2;
HbA1c levels as follows at Screening:

Key exclusion criteria (20 listed)

History of type 1 diabetes and/or history of ketoacidosis;
History of chronic (>2 months) use of insulin therapy or recent initiation of insulin use intended for chronic administration;
Use of TZD (pioglitazone or rosiglitazone) or exenatide within 3 months prior to Screening;
Use of prescription or over the counter weight loss agents within 1 month prior to Screening;
Use of any lipid-altering, antihypertensive, and other chronic use medication not stable for 1 month prior to Screening;

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
placeboplacebo capsule,0 units, quater in die (QID) for 18 weeks	Drug	1; Placebo
Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)Oral HDV-I Caps; 15 U; quater in die (QID) for 18 weeks.	Drug	3; Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)
Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)Oral HDV-I; Caps; 5 U; quater in die (QID) for 18 weeks.	Drug	2; Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)

Primary outcome

The primary objective of this trial is to compare the reduction in mean glycated hemoglobin levels (HbA1c) between 2 doses of oral HDV-I and placebo in type 2 diabetic patients on background metformin therapy at the end of 18 weeks of treatment.
Time frame: 18 weeks

4 secondary outcomes

To evaluate the effects of oral HDV-I versus placebo on the 7-point glucose test
Time frame: 18 weeks
To evaluate the effects of oral HDV-I versus placebo on fasting plasma glucose (FPG) and insulin
Time frame: 18 weeks
To evaluate the effects of oral HDV-I versus placebo on the homeostasis model assessment of insulin resistance (HOMA-IR)and homeostasis model assessment of β-cell function (HOMA-β)
Time frame: 18 Weeks
To evaluate the effects of oral HDV-I versus placebo on frequency of hypoglycemic events, body weight, and lipid levels
Time frame: 18 Weeks

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 26 May 2021.

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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.

Len Rosenberg, PhD, RPh study director

Diasome Pharmaceuticals

David Orloff, MD study director

Medpace, Inc.

40 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 14 inclusion and 20 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 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00814294.

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 26 May 2021.