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NCT00694122 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Massachusetts General Hospital.

Completed
Registry status
Phase 3
Development phase
27
Enrollment target

NCT00694122: Completed Phase 3 study, sponsored by Massachusetts General Hospital.

NCT00694122 is a Phase 3 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 27 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00694122, a Phase 3 study, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
Phase 3
Development phase
27 participants
Enrollment target

Study Summary

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.

Primary Outcome

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.

Interventions

  • DRUG Lantus (glargine)

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2005-06
Est. Completion 2010-11
Phase Phase 3
Massachusetts General Hospital

2,032 total trials

What the finished NCT00694122 record still lists

NCT00694122 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which Lantus (glargine) is the first listed.

NCT00694122 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00694122 about?

NCT00694122 is a clinical study titled "Comparison of Lantus and Neutral Protamine Hagedorn (NPH) Insulin in the Dawn Phenomenon". 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.

What is the current status of trial NCT00694122?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 27 participants. The study started on 2005-06. Estimated completion is 2010-11.

What interventions are being tested in trial NCT00694122?

The interventions under investigation include: Lantus (glargine) (DRUG).

Who is sponsoring clinical trial NCT00694122?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00694122's enrollment target sits among peer trials

27 1936th of 2000 higher than 64 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00694122, the US trial registry maintained by the National Library of Medicine. NCT00694122 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.