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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Comparison of Lantus and Neutral Protamine Hagedorn (NPH) Insulin in the Dawn Phenomenon

Short name DAWN

NCTNCT00694122 (opens ClinicalTrials.gov in a new tab)Other id2005-P-002515/24
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures Glucagon, does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Phase 3
Enrollment
27 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
Jun 2005
Primary completion
Nov 2010
Completion
Nov 2010
First posted
10 Jun 2008 (estimated)
Last update posted
21 Oct 2014 (estimated)
Conditions
Type 1 Diabetes · Dawn Phenomenon

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2005200620072008200920102011
  1. Ph 3

    DAWN

    NCT00694122

    Jun 2005 to Nov 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

1. To investigate the effect of insulin glargine (Lantus™) vs NPH insulin regarding glycemic control during the early AM (dawn phenomenon) in individuals with type 1 diabetes. 2. To measure hormones implicated in the pathogenesis of the dawn phenomenon in individuals with type 1 diabetes.

Interventions

  • Lantus (glargine)Drug

Arms2

  • Active comparator

    Glargine (Lantus) insulin

    Long acting insulin, glargine, that subject currently used as an outpatient. SC injections. Dose given at 22:00 is based on past week blood glucose data during evening overnight hours and AM glucose. 20.2 +/- 11.7 units glargine (mean +/- SD). Glargine (Lantus): Sanolfi Aventis Hourly blood glucose from 22:00 to 08:00 while receiving glargine (Lantus) insulin will be compared with the NPH insulin arm.

  • Active comparator

    NPH insulin

    Long acting insulin, NPH, that participant was currently while an outpatient. SC injections. Dose (units) given at 22:00 is based on past week blood glucose during evening overnight period and AM glucose. 20.7 +/- 10.0 units NPH (mean +/- SD). NPH: Eli Lilly Hourly blood glucose from 22:00 to 08:00 while receiving glargine (Lantus) insulin will be compared with the glargine (Lantus) insulin arm.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Blood Glucose Area Under the Curve (AUC)

    Time frame · Overnight

    Registry description

    Cumulative sum of repeatedly measured blood glucose values (mg/dl) beginning at 22:00, then hourly till 08:00. Participants were monitored during two overnight sampling periods. One overnight was while the participant was on neutral protamine Hagedorn (NPH) insulin as the long acting insulin; the other overnight was glargine (Lantus) insulin as the the long acting insulin.

  2. Blood Glucose

    Time frame · Overnight

    Registry description

    Average value of repeatedly measured absolute values beginning at 22:00, then hourly till 08:00. Participants were monitored during two overnight sampling periods. One overnight was while the participant was on NPH insulin as the long acting insulin; the other overnight was glargine(Lantus) insulin as the the long acting insulin.

Secondary outcomes(4)

  1. Insulin Dose

    Time frame · Overnight

    Registry description

    NPH or glargine (Lantus) was given at 22:00 to provide blood glucose coverage during the overnight hours.

  2. Cortisol

    Time frame · Overnight

    Registry description

    Mean cortisol nmol/l during NPH or glargine (Lantus) overnight visit. Hourly cortisol was determined from 22:00 to 8:00.

  3. Glucagon

    Time frame · Overnight

    Registry description

    Mean glucagon mcg/l during NPH or glargine (Lantus) overnight visit. Hourly glucagon was determined from 22:00 to 8:00.

  4. Growth Hormone

    Time frame · Overnight

    Registry description

    Mean growth hormone ug/l during NPH or glargine (Lantus) overnight visit. Hourly growth hormone was determined from 22:00 to 8:00.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Overnight

Blood Glucose Area Under the Curve (AUC)

GroupValue (mg*10hr/dL)Spread
Glargine (Lantus) Insulin1673.33760.7
NPH Insulin1395384.9
Primary outcomeMean· Overnight

Blood Glucose

GroupValue (mmol/l)Spread
Glargine (Lantus) Insulin9.60.3
NPH Insulin7.93.7
Secondary and other outcome results(4)
Secondary outcomeMean· Overnight

Insulin Dose

GroupValue (units)Spread
Glargine (Lantus) Insulin20.211.7
NPH Insulin20.710.0
Secondary outcomeMean· Overnight

Cortisol

GroupValue (nmol/l)Spread
Glargine (Lantus)380.45143.48
NPH Insulin388.61122.1
Secondary outcomeMean· Overnight

Glucagon

GroupValue (mcg/l)Spread
Glargine (Lantus) Insulin58.819.0
NPH Insulin54.319.0
Secondary outcomeMean· Overnight

Growth Hormone

GroupValue (ug/l)Spread
Glargine (Lantus) Insulin1.091.61
NPH Insulin1.272.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
NPH InsulinIndividuals on NPH insuling as long acting insulin.–0 / 150 / 15
Lantus InsulinIndividuals on Lantus insulin as long acting insulin.–0 / 150 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Written informed consent obtained prior to performing screening evaluations. * Male or female, 18 yrs or older. * Diagnosis of type 1 diabetes made 5 years prior to screening visit. * A1C \> 6.0% and 9.0% at screening visit. * Body Mass Index (BMI) 35 kg/m2 at screening visit. * Documented undetectable C-Peptide * Ability to follow instructions for Continuous Glucose Monitoring System (CGMS). * Multiple daily injection participants on at least 3 injections per day. May be treated with NPH or glargine. Exclusion Criteria: * Pregnant or lactating females, or females planning to become pregnant during the study or not using an acceptable method of contraception. Females of childbearing potential must have a negative pregnancy test at Visit 3 and Visit 5. Females who become pregnant during the study will be discontinued. * Type 2 diabetes. * Two or more severe hypoglycemic episodes (requiring assistance) within six months of Screening. * Drugs known to affect glycemia (eg. steroids, beta blockers) or conditions that are likely to require steroid therapy or cause metabolic instability in the next 6 months. * History of allergy or intolerance to NPH or glargine. * History of hypoglycemia unawareness i.e. no warning symptoms accompanying low (\<50 mg/dl) blood glucose levels. * Unable and/or unlikely to comprehend and/or follow the study protocol (including self blood glucose monitoring, CGMS). * Currently using an insulin pump. * Pituitary disorder (Acromegaly, Cushing's, Hypothyroidism etc.) or tumor. * Two or more severe hypoglycemic episodes (requiring assistance) within six months of Screening.

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