Type 1 DiabetesNCT00869414
Glycemic Effects of Morning Only, Evening Only or Twice Daily Insulin Glargine in Patients With Type 1 Diabetes
A study testing Evening only administration of insulin glargine, Morning only administration of insulin glargine and split dose insulin glargine in people with Type 1 Diabetes and Hypoglycemia, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is a prospective, randomized, cross-over study that is being done to compare the effect of morning only, evening only and twice daily insulin glargine (Lantus®) on hypoglycemia (blood glucose level <70 mg/dL) as measured by continuous glucose monitoring (CGM) in patients with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Type 1 Diabetes, Hypoglycemia
- What is being tested?
- Evening only administration of insulin glargine, Morning only administration of insulin glargine and split dose insulin glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Mar 2010
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men and women above age 18 with a diagnosis of type 1 diabetes mellitus
- On multiple insulin injections, including a long acting or intermediate acting insulin preparation and mealtime short acting insulin preparation.
- Clinical history consistent with hypoglycemia
- Hba1c <9.0%
Who cannot join
- Patients with type 2 diabetes mellitus
- Patients on insulin pump
- Poor control of diabetes (HbA1c > 9.0%)
- Pregnancy (women of childbearing age will undergo a pregnancy test at the start of the study and will be advised to use birth control methods during the study). Insulin glargine has been reported to have teratogenic effects in animal models, and therefore should only be used during pregnancy if clearly needed.
- Serious co-morbidities that, in clinical opinion of the investigators, could affect pharmacokinetics of glargine (e.g., CRF) or safety (e.g., recent CAD)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Glycemic Response to Morning Only, Evening Only or Twice Daily Insulin Glargine in Patients With Type 1 Diabetes Using Continuous Glucose Monitoring
This research is a prospective, randomized, cross-over study that is being done to compare the effect of morning only, evening only and twice daily insulin glargine (Lantus®) on hypoglycemia (blood glucose level <70 mg/dL) as measured by continuous glucose monitoring (CGM) in patients with type 1 diabetes.
Read the detailed description
Over the course of the 6 week study, patients will take insulin glargine in each of 3 different times: only in the morning, only at night, and half in the morning, half at night. After 2 weeks taking the insulin in one regimen, patients will be switched to another regimen. Through the whole study, patients will be injecting themselves twice daily, and neither the patient nor the treating doctor will know which vials contain the insulin and which have only saline (placebo). The vials will be labeled MORNING or EVENING. Patients will continue to take their mealtime, short acting insulin doses.
Additionally, patients will wear a continuous glucose monitor (CGM) which will be masked. Before the study, patients will be taught about how to use the CGM, and keep it taped to their abdomen. The site that the CGM inserts into their abdomen will need to be changed every 5 days. We will know if a patients' blood sugar goes low even if the patient did not feel the low. Patients will still have to self-monitor their blood sugar levels at-least four times in five days, to calibrate the CGM.
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Being tested
- Evening only administration of insulin glargine, Morning only administration of insulin glargine, split dose insulin glargine
- Keywords
- hypoglycemia, type 1 diabetes, split dosing insulin glargine, continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evening only administration of insulin glargineDrug
Also called Lantus
Evening only administration of insulin glargine, with normal saline injection administered in the morning.
Morning only administration of insulin glargineDrug
Also called Lantus
Morning only administration of insulin glargine, with normal saline injection administered at night.
split dose insulin glargineDrug
Also called Lantus
split dose of insulin glargine, half administered in the morning, half administered in evening
| Study group | Role | What they receive |
|---|---|---|
| insulin glargine only in morning | Active comparator | Morning only administration of insulin glargine Receives: Drug: Morning only administration of insulin glargine |
| insulin glargine only at evening | Active comparator | Evening only administration of insulin glargine Receives: Drug: Evening only administration of insulin glargine |
| split dose insulin glargine | Active comparator | Split dose administration of insulin glargine, half dose in morning, half dose in evening Receives: Drug: split dose insulin glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Spent (Mean Number of Minutes Per 24 Hour Day) in Hypoglycemic Range (<70mg/dl)
Measured: 6 weeks
Change in the Mean Minutes Per 24 Hour Day in the Hyperglycemic Range of > 180 mg/dL.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startJul 2009
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: PI deceased
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 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher D Saudek, MD, Principal investigator, Johns Hopkins UniversityAri S Eckman, MD, Study director, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869414
- Sponsor's protocol ID
- NA_00024168
- Status last verified
- May 2017
- First submitted
- 25 Mar 2009
- Last updated
- 29 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Garg SK, Gottlieb PA, Hisatomi ME, D'Souza A, Walker AJ, Izuora KE, Chase HP. Improved glycemic control without an increase in severe hypoglycemic episodes in intensively treated patients with type 1 diabetes receiving morning, evening, or split dose insulin glargine. Diabetes Res Clin Pract. 2004 Oct;66(1):49-56. doi: 10.1016/j.diabres.2004.02.008.
PubMed 15364161Ashwell SG, Gebbie J, Home PD. Twice-daily compared with once-daily insulin glargine in people with Type 1 diabetes using meal-time insulin aspart. Diabet Med. 2006 Aug;23(8):879-86. doi: 10.1111/j.1464-5491.2006.01913.x.
PubMed 16911626
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Glycemic Response to Morning Only, Evening Only or Twice Daily Insulin Glargine in Patients With Type 1 Diabetes Using Continuous Glucose Monitoring
- ClinicalTrials.gov ID
- NCT00869414
- Acronym / sponsor ID
- NA_00024168
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Keywords
- hypoglycemia, type 1 diabetes, split dosing insulin glargine, continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI deceased
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jul 2009 (actual)
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 26 Mar 2009 (estimated)
- Results
- Posted 29 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is a prospective, randomized, cross-over study that is being done to compare the effect of morning only, evening only and twice daily insulin glargine (Lantus®) on hypoglycemia (blood glucose level <70 mg/dL) as measured by continuous glucose monitoring (CGM) in patients with type 1 diabetes.
Detailed description
Over the course of the 6 week study, patients will take insulin glargine in each of 3 different times: only in the morning, only at night, and half in the morning, half at night. After 2 weeks taking the insulin in one regimen, patients will be switched to another regimen. Through the whole study, patients will be injecting themselves twice daily, and neither the patient nor the treating doctor will know which vials contain the insulin and which have only saline (placebo). The vials will be labeled MORNING or EVENING. Patients will continue to take their mealtime, short acting insulin doses.
Additionally, patients will wear a continuous glucose monitor (CGM) which will be masked. Before the study, patients will be taught about how to use the CGM, and keep it taped to their abdomen. The site that the CGM inserts into their abdomen will need to be changed every 5 days. We will know if a patients' blood sugar goes low even if the patient did not feel the low. Patients will still have to self-monitor their blood sugar levels at-least four times in five days, to calibrate the CGM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| insulin glargine only in morning | Active comparator | Drug: Morning only administration of insulin glargineMorning only administration of insulin glargine |
| insulin glargine only at evening | Active comparator | Drug: Evening only administration of insulin glargineEvening only administration of insulin glargine |
| split dose insulin glargine | Active comparator | Drug: split dose insulin glargineSplit dose administration of insulin glargine, half dose in morning, half dose in evening |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult men and women above age 18 with a diagnosis of type 1 diabetes mellitus
- On multiple insulin injections, including a long acting or intermediate acting insulin preparation and mealtime short acting insulin preparation.
- Clinical history consistent with hypoglycemia
- Hba1c <9.0%
Key exclusion criteria (5 listed)
- Patients with type 2 diabetes mellitus
- Patients on insulin pump
- Poor control of diabetes (HbA1c > 9.0%)
- Pregnancy (women of childbearing age will undergo a pregnancy test at the start of the study and will be advised to use birth control methods during the study). Insulin glargine has been reported to have teratogenic effects in animal models, and therefore should only be used during pregnancy if clearly needed.
- Serious co-morbidities that, in clinical opinion of the investigators, could affect pharmacokinetics of glargine (e.g., CRF) or safety (e.g., recent CAD)
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 |
|---|---|---|
| Evening only administration of insulin glargineAlso: LantusEvening only administration of insulin glargine, with normal saline injection administered in the morning. | Drug | insulin glargine only at evening |
| Morning only administration of insulin glargineAlso: LantusMorning only administration of insulin glargine, with normal saline injection administered at night. | Drug | insulin glargine only in morning |
| split dose insulin glargineAlso: Lantussplit dose of insulin glargine, half administered in the morning, half administered in evening | Drug | split dose insulin glargine |
Primary outcome
Time Spent (Mean Number of Minutes Per 24 Hour Day) in Hypoglycemic Range (<70mg/dl)
Time frame: 6 weeks
Change in the Mean Minutes Per 24 Hour Day in the Hyperglycemic Range of > 180 mg/dL.
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15364161Garg SK, Gottlieb PA, Hisatomi ME, D'Souza A, Walker AJ, Izuora KE, Chase HP. Improved glycemic control without an increase in severe hypoglycemic episodes in intensively treated patients with type 1 diabetes receiving morning, evening, or split dose insulin glargine. Diabetes Res Clin Pract. 2004 Oct;66(1):49-56. doi: 10.1016/j.diabres.2004.02.008.
- Background: PubMed 16911626Ashwell SG, Gebbie J, Home PD. Twice-daily compared with once-daily insulin glargine in people with Type 1 diabetes using meal-time insulin aspart. Diabet Med. 2006 Aug;23(8):879-86. doi: 10.1111/j.1464-5491.2006.01913.x.
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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.
Christopher D Saudek, MD principal investigator
Johns Hopkins University
Ari S Eckman, MD study director
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evening only administration of insulin glargine, Morning only administration of insulin glargine and split dose insulin glargine in people with Type 1 Diabetes and Hypoglycemia, run by Johns Hopkins University 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 29 Jun 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2017). 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?
Time Spent (Mean Number of Minutes Per 24 Hour Day) in Hypoglycemic Range (<70mg/dl) (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 NCT00869414, 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 29 Jun 2017.