Type 2 Diabetes MellitusPhase 4NCT00686712
Insulin Glargine at Bedtime or in AM Versus NPH
A Phase 4 study testing 1- Insulin glargine QHS, 2 - Insulin glargine QAM and 3 - NPH insulin QHS in people with Type 2 Diabetes Mellitus, run by Charles Drew University of Medicine and Science at 1 site in United States.
Trial summary
To compare the efficacy and safety of once-nightly insulin glargine versus a single morning injection of glargine or once-nightly NPH insulin in ethnic minority type 2 diabetic patients inadequately controlled on combination oral agents. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- 1- Insulin glargine QHS, 2 - Insulin glargine QAM and 3 - NPH insulin QHS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Aug 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 18-75
- Type 2 diabetes diagnosed for at least 1 year
- Treatment with stable doses of oral agents (alone or in combination) for at least 2 months
- Inadequate glycemic control (hemoglobin A1c ≥ 7.5%) on maximum-tolerated doses of a sulfonylurea, metformin and a thiazolidinedione
- No past history of chronic insulin use (other than treatment of gestational diabetes or hospitalizations of less than 1 week in duration)
- Hemoglobin A1c between 7.5% and 12%
- Body mass index (BMI) between 20 and 40 kg/m2
Who cannot join
- Current or previous chronic use of insulin (other than for treatment of gestational diabetes)
- History of confirmed (or clinical suspicion of) type 1 diabetes
- Female subjects of childbearing potential who are sexually active and not using a reliable form of contraception
- Current pregnancy or lactation.
- Subjects for whom insulin therapy is contraindicated or for whom, in the opinion of the investigator, therapy with insulin is not indicated
- Subjects with advanced proliferative diabetic retinopathy
Show all 11Show fewer
- Subjects who work night shifts or who are unable to stay on a consistent daily meal schedule
- History of any clinically significant renal, hepatic, cardiovascular, neurological, endocrinological or other major systemic disease that, in the opinion of the investigator, may make implementation of the protocol or interpretation of the data difficult.
- Subjects who will likely require or initiate therapy with drugs which may interfere with glucose metabolism during the course of the study
- Subjects who are in another investigational study or have received another investigational medication within 30 days of study entry
- Subjects who are unable or unwilling to comply with all components of the study protocol, including contacting the investigators at specified times and attending all scheduled follow-up visits.
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles Drew University of Medicine and Science
Los Angeles, California, 90059
About this study
Official title: The Utility of Insulin Glargine (Lantus) Compared to NPH in Ethnic Minority Type 2 Diabetic Subjects Starting Insulin Therapy
To compare the efficacy and safety of once-nightly insulin glargine versus a single morning injection of glargine or once-nightly NPH insulin in ethnic minority type 2 diabetic patients inadequately controlled on combination oral agents.
Read the detailed description
Insulin glargine has a longer action than compared to NPH insulin, but whether this results in improved control when used as a once-nightly or morning basal insulin injection in type 2 diabetic patients who are inadequately controlled on combination oral agents has been controversial. Inner city ethnic minority patients with diabetes are a particularly challenging population of diabetic patients to treat. This study investigates whether insulin glargine may be a more effective or safer first-line basal insulin than NPH in this population.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- 1- Insulin glargine QHS, 2 - Insulin glargine QAM, 3 - NPH insulin QHS
- Keywords
- Glargine, Type 2 diabetes, Basal insulin
- 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.
1- Insulin glargine QHSDrug
Also called Trade name: Lantus
Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL)
2 - Insulin glargine QAMDrug
Also called Trade name: Lantus
Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL)
3 - NPH insulin QHSDrug
Also called (Generic)
NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)
| Study group | Role | What they receive |
|---|---|---|
| 1 - Insulin glargine QHS | Experimental | Insulin glargine injected subcutaneously once daily at bedtime Receives: Drug: 1- Insulin glargine QHS |
| 2 - Insulin glargine QAM | Experimental | Insulin glargine injected subcutaneously once daily in the morning Receives: Drug: 2 - Insulin glargine QAM |
| 3 - NPH Insulin QHS | Active comparator | NPH insulin injected subcutaneously once daily at bedtime Receives: Drug: 3 - NPH insulin QHS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c Change From Baseline
Measured: Baseline to 6 months
Secondary outcomes (6)
Frequency of Glucose Readings < 130 mg/dL
Frequency of glucose readings below the recommended pre-meal glucose target of 130 mg/dL
Measured: 6 months
Frequency of Total Hypoglycemic Reactions
Frequency of hypoglycemic reactions without regard to time of occurrence
Measured: 6 months
Frequency of Severe Hypoglycemic Reactions
Frequency of severe hypoglycemic reactions, defined as those requiring the assistance of another person
Measured: 6 months
Body Mass Index Change From Baseline
Change in body mass index from baseline BMI measurement
Measured: 6 months
Total Daily Insulin Dose
Total daily number of units of insulin used
Measured: 6 months
Any Adverse Event Other Than Hypoglycemia
Any reported adverse event that is not hypoglycemia
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study startFeb 2003
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Responsible party
- Sponsor
- Investigators
- Stanley Hsia, MD, Principal investigator, Charles Drew University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686712
- Sponsor's protocol ID
- 03-02-524
- Other IDs
- U54RR014616
- Status last verified
- Apr 2017
- First submitted
- 27 May 2008
- Last updated
- 22 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
PubMed 33166419Hsia SH. Insulin glargine compared to NPH among insulin-naive, U.S. inner city, ethnic minority type 2 diabetic patients. Diabetes Res Clin Pract. 2011 Mar;91(3):293-9. doi: 10.1016/j.diabres.2010.11.028. Epub 2010 Dec 13.
PubMed 21146881
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Insulin Glargine (Lantus) Compared to NPH in Ethnic Minority Type 2 Diabetic Subjects Starting Insulin Therapy
- ClinicalTrials.gov ID
- NCT00686712
- Acronym / sponsor ID
- 03-02-524
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Glargine, Type 2 diabetes, Basal insulin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Feb 2003
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 30 May 2008 (estimated)
- Results
- Posted 7 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy and safety of once-nightly insulin glargine versus a single morning injection of glargine or once-nightly NPH insulin in ethnic minority type 2 diabetic patients inadequately controlled on combination oral agents.
Detailed description
Insulin glargine has a longer action than compared to NPH insulin, but whether this results in improved control when used as a once-nightly or morning basal insulin injection in type 2 diabetic patients who are inadequately controlled on combination oral agents has been controversial. Inner city ethnic minority patients with diabetes are a particularly challenging population of diabetic patients to treat. This study investigates whether insulin glargine may be a more effective or safer first-line basal insulin than NPH in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 - Insulin glargine QHS | Experimental | Drug: 1- Insulin glargine QHSInsulin glargine injected subcutaneously once daily at bedtime |
| 2 - Insulin glargine QAM | Experimental | Drug: 2 - Insulin glargine QAMInsulin glargine injected subcutaneously once daily in the morning |
| 3 - NPH Insulin QHS | Active comparator | Drug: 3 - NPH insulin QHSNPH insulin injected subcutaneously once daily at bedtime |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, age 18-75
- Type 2 diabetes diagnosed for at least 1 year
- Treatment with stable doses of oral agents (alone or in combination) for at least 2 months
- Inadequate glycemic control (hemoglobin A1c ≥ 7.5%) on maximum-tolerated doses of a sulfonylurea, metformin and a thiazolidinedione
- No past history of chronic insulin use (other than treatment of gestational diabetes or hospitalizations of less than 1 week in duration)
Key exclusion criteria (11 listed)
- Current or previous chronic use of insulin (other than for treatment of gestational diabetes)
- History of confirmed (or clinical suspicion of) type 1 diabetes
- Female subjects of childbearing potential who are sexually active and not using a reliable form of contraception
- Current pregnancy or lactation.
- Subjects for whom insulin therapy is contraindicated or for whom, in the opinion of the investigator, therapy with insulin is not indicated
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 |
|---|---|---|
| 1- Insulin glargine QHSAlso: Trade name: LantusInsulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL) | Drug | 1 - Insulin glargine QHS |
| 2 - Insulin glargine QAMAlso: Trade name: LantusInsulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL) | Drug | 2 - Insulin glargine QAM |
| 3 - NPH insulin QHSAlso: (Generic)NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL) | Drug | 3 - NPH Insulin QHS |
Primary outcome
Hemoglobin A1c Change From Baseline
Time frame: Baseline to 6 months
6 secondary outcomes
Frequency of Glucose Readings < 130 mg/dL
Time frame: 6 months
Frequency of Total Hypoglycemic Reactions
Time frame: 6 months
Frequency of Severe Hypoglycemic Reactions
Time frame: 6 months
Body Mass Index Change From Baseline
Time frame: 6 months
Total Daily Insulin Dose
Time frame: 6 months
Any Adverse Event Other Than Hypoglycemia
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33166419Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
- Derived from this study: PubMed 21146881Hsia SH. Insulin glargine compared to NPH among insulin-naive, U.S. inner city, ethnic minority type 2 diabetic patients. Diabetes Res Clin Pract. 2011 Mar;91(3):293-9. doi: 10.1016/j.diabres.2010.11.028. Epub 2010 Dec 13.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Stanley Hsia, MD principal investigator
Charles Drew University of Medicine and Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1- Insulin glargine QHS, 2 - Insulin glargine QAM and 3 - NPH insulin QHS in people with Type 2 Diabetes Mellitus, run by Charles Drew University of Medicine and Science at 1 site 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 7 inclusion and 11 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 22 May 2017. 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hemoglobin A1c Change From Baseline (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00686712, which also lists 2 linked publications.
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 22 May 2017.